A novel cognitive-behavioral approach for treatment-resistant drug dependence

Journal of Substance Abuse Treatment 23 (2002) 335 – 342

Regular article

A novel cognitive-behavioral approach for treatment-resistant drug dependence Mark H. Pollack, M.D.a,b,*, Susan A. Penava, Ph.D.a, Elisa Bolton, Ph.D.a, John J. Worthington III, M.D.a, Gretchen Lanka Allen, B.A.a, Francisco J. Farach Jr., B.A.a, Michael W. Otto, Ph.D.a a

Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA b Habit Management Institute, Boston, MA 02118, USA Received 22 March 2002; received in revised form 28 June 2002; accepted 5 July 2002

Abstract Despite the application of treatments that combine methadone administration, weekly counseling, and contingency reinforcement strategies, many opiate-dependent patients continue illicit drug use. In this controlled study we piloted a novel cognitive-behavioral treatment (CBT) designed to reduce illicit drug use among patients receiving methadone treatment. The treatment targeted the reduction of sensitivity to interoceptive cues associated with drug craving, and trained alternative responses to these cues. Patients (N = 23) were randomly assigned to either this novel CBT program or a program of increased counseling, such that the two programs of treatment were equated for therapist contact, assessment time, and contingency-reinforcement strategies. We found that, compared to a doubling of contact with their outpatient counselor, the new program was associated with significantly greater reductions in illicit drug use for women, but not for men. Reasons for differential performance by women and men and future directions for this new treatment are discussed. D 2002 Elsevier Science Inc. All rights reserved. Keywords: Illicit drug use; Behavior therapy; Cognitive therapy; Treatment-resistant; Opiate dependence; Sex differences

1. Introduction Methadone treatment, counseling, and contingency-management strategies (e.g., contingent take-home methadone) have each been found to reduce illicit drug use among opiatedependent outpatients (Hartz et al., 1999; Iguchi, Belding, Morral, Lamb, & Husband, 1997; Stitzer, Iguchi, & Felch, 1992; Ward, Hall, & Mattick, 1999; Ward, Mattick, & Hall, 1994), and integrated methadone treatment programs commonly use a combination of these strategies in their clinical programs (Ball & Ross, 1991). However, concurrent illicit drug use is common among methadone-treated patients, with over 50% of patients using other drugs and alcohol (Nurco, Kinlock, Hanlon, & Ball, 1988; San, Cami, Peri, Mata, & Porta, 1990; Stitzer et al., 1992; Woody, McLellan, Luborsky, * Corresponding author. Massachusetts General Hospital, WACC-812, 15 Parkman St., Boston, MA 02114, USA. Tel: +1-617-724-0844; fax: +1617-726-7541. E-mail address: [email protected] (M.H. Pollack).

& O’Brien, 1990). Moreover, this occurs despite the use of integrated programs of methadone treatment, weekly drug counseling, and contingency-management strategies (Ball & Ross, 1991; Stitzer et al., 1992). Continued illicit drug use despite treatment places patients at risk for a number of adverse consequences, including disrupted psychosocial and vocational function, illegal activity, and poor health, including risk of HIV infection (Zweben, 1990). The importance of contextual cues in triggering and perpetuating drug use is reflected in a number of conditioning theories of drug dependence. In general, these theories discuss the importance of the distinctive environments that are repeatedly associated with drug effects, and how such environments can elicit drug craving (Rohsenow, Childress, Monti, Niaura, & Abrams, 1990 –1991; Rohsenow & Monti, 1999). Accordingly, various environmental contextual cues for drug seeking or drug taking behaviors have been identified as potential targets for exposure interventions (Monti et al., 1993; Niaura et al. 1988; Raw & Russell, 1980), and treatments based on these approaches have provided encouraging

0740-5472/02/$ – see front matter D 2002 Elsevier Science Inc. All rights reserved. PII: S 0 7 4 0 - 5 4 7 2 ( 0 2 ) 0 0 2 9 8 - 2

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results (e.g., Franken, De Haan, Van Der Meer, Haffmans, & Hendriks, 1999; O’Brien, Childress, McLellan, & Ehrman, 1990; Powell et al., 1990; Powell, Gray, & Bradley, 1993). Nonetheless, one limitation of external drug cue-exposure procedures (e.g., exposure to the sights and smells of substance use) is that drug craving may be reduced in the context of the clinic, but may persist in natural settings for drug abuse (O’Brien et al., 1990). In addition, these procedures are focused on external cues, despite research indicating that many of the contextual cues for drug abuse are interoceptive (largely emotional) rather than environmental (Marlatt & Gordon, 1980; O’Connell & Martin, 1987; Wikler, 1965). For example, in a retrospective study of opiate abusers, interoceptive cues accounted for the majority of reasons for relapses: 32% of relapses occurred after negative emotional states, 32% after negative physical states not characterized by withdrawal-like symptoms, 16% after withdrawal-like states, and 5% after positive emotional states (Chaney, Roszell, & Cummings, 1982). Likewise, drug craving in the laboratory appears to be enhanced by the induction of negative mood states (Childress et al., 1994; Sherman, Zinser, Sideroff, & Baker, 1989) as well as naturally occurring negative moods (Robbins, Ehrman, Childress, Cornish, & O’Brien, 2000). An alternative treatment approach is to help patients change their responses to interoceptive cues associated with drug use. This approach has the potential of helping patients change their responses to craving cues, regardless of the situation in which these sensations or mood states are elicited. Accordingly, we designed a novel treatment that emphasizes interventions to help patients tolerate and respond with self-control techniques (e.g., cognitive coping procedures, over-rehearsed behavioral responses, or relaxation or diaphragmatic breathing) to the emotional and somatic cues associated with drug craving. This treatment was based on the successful application of a program emphasizing interoceptive exposure plus cognitive-restructuring among patients with panic disorder who are experiencing difficulties discontinuing their benzodiazepine medications (Otto, Pollack, Meltzer-Brody, & Rosenbaum, 1992; Otto et al., 1993; Otto, Pollack, Ball, & Rosenbaum, 1995). For the initial pilot evaluation of our new treatment, we selected a cohort of patients who were failing available and accepted strategies to control illicit drug use among opiate-dependent patients: specifically, the combination of methadone treatment, counseling, and contingency management. Moreover, we used an enhanced-counseling treatment to assess whether our novel treatment was more effective than a simple intensification of existing treatment.

2. Materials and methods 2.1. Participants Participants were 23 outpatients who failed to control their illicit drug use despite 3 months or more of regular attendance

in a methadone treatment program utilizing weekly counseling. To be eligible for the study, patients had to meet Diagnostic and Statistical Manual of Mental Disorders, Third Edition-Revised (DSM-III-R; American Psychiatric Association, 1987) criteria for opiate dependence; maintain a stable dose of methadone treatment for 1 month prior to recruitment; have at least one toxicological screen positive for illicit drug use in the month before study entry; and demonstrate ongoing drug abuse as evidenced by: (a) never having two consecutive toxicology screens free of illicit substances since entering the current treatment episode: and (b) failing to achieve take-home status during the current treatment episode. Patients thought to meet these inclusion criteria were approached by their counselor and asked whether they wished to consider participation. Exclusion criteria included: (a) unstable or uncontrolled medical illness which might interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period); (b) schizophrenia, psychosis, or organic mental disorder by DSM-III-R criteria or uncontrolled bipolar disorder; (c) use of medication affecting methadone metabolism (e.g., rifampin); (d) homelessness or other living situations that would preclude availability of a stable setting in which to perform therapy assignments. Interested patients provided written informed consent and were scheduled for a diagnostic evaluation. Twenty– three patients provided written informed consent, completed baseline assessment, and were randomized to treatment: 12 patients to cognitive-behavior therapy for interoceptive cues (CBT-IC), and 11 to the enhanced treatment-as-usual (TAU+) comparison condition. 2.2. Procedures All procedures in this study were conducted in accord with the standards of the Massachusetts General Hospital Subcommittee on Human Subjects. Patients were assessed for substance use, anxiety, and affective disorders, somatization disorders, and psychosis at the screening visit using the Structured Clinical Interview for DSM-III-R (SCID; Spitzer, Williams, Gibbon, & First, 1992). Patients also completed the Personality Disorder Questionnaire-Revised to provide an index of Axis II diagnoses (PDQ-R; Hyler & Rieder, 1987). Patients entering the protocol then completed baseline assessments and were block-randomized according to methadone dose (  50 mg/day vs. < 50 mg/day) and sex (male or female). Baseline and outcome assessments included both objective and clinician-rated instruments as detailed below. In an effort to maximize compliance with the interventions (and assessment visits), a monetary reinforcement system was employed. This was consistent with findings from studies by Higgins et al. (1991), Higgins, Budney, Bickel, Foerg, and Badger (1993), and Silverman, Brooner, Montoya, Schuster, and Preston (1994) that demonstrated the effectiveness of voucher reinforcement systems in improving retention in treatment, improving cocaine abstinence in cocaine abusers, and decreasing supplemental

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cocaine use in methadone-maintained patients. Patients were given an increasing schedule of compensation for attendance to the treatment to which they were assigned (starting at $10 and increasing by $10 increments up to $30); if a patient missed a session she or he returned to the $10 starting point. Patients were also compensated for the independent evaluation visits. 2.3. Outcome assessments The primary outcome variable for this study was the percentage of urine screens that were negative for illicit substances. This objective measure was complemented by patients’ self-report of the degree and impact of drug use as assessed by the Addiction Severity Index. Other secondary outcome measures included the severity of anxiety and depression symptoms as assessed by the Hamilton rating scales for anxiety (Hamilton, 1959) and depression (Hamilton, 1960). Patients had supervised urine toxicologic screens performed randomly once per week from the baseline visit through the 6-month follow-up period. The study utilized the ETS Plus EMIT system (Syva Co., Palo Alto, CA) for urine toxicology screens for opiates, methadone, cocaine, propoxyphene, benzodiazepines, amphetamines, THC, and barbiturates. 2.3.1. Addiction Severity Index (ASI) The Addiction Severity Index is a structured, clinicianadministered interview designed to evaluate treatment outcome in substance abusing populations (McLellan, Luborsky, Woody, & O’Brien, 1980). The instrument gathers information about aspects of the patient’s life that may contribute to or reflect substance abuse. Patients are asked to use a 5-point scale (0 = ‘‘Not at all,’’ 4 = ‘‘Extremely’’) in response to questions regarding seven areas in their life that include drug/alcohol use (e.g., ‘‘How many times in your life have you been treated for: Alcohol abuse? Drug abuse?’’). High inter-rater reliability (r = .89) and test-retest reliability (r = .92) have been reported for the ASI (McLellan et al., 1985). This instrument was used as a baseline predictor and an outcome variable, and was assessed at baseline, endpoint of treatment, and at the follow-up assessments. For the present study, we used the drug and alcohol use subscales. 2.3.2. Hamilton Anxiety Rating Scale (HARS) The 14-item HARS (Hamilton, 1959) was developed to assess anxiety in a clinical population. This instrument was used as a baseline predictor and a secondary outcome variable, and was assessed at the baseline, endpoint of treatment, and at the follow-up assessments. 2.3.3. Hamilton Rating Scale for Depression (HRSD) The revised HRSD (Hamilton, 1960) is a 21-item measure designed to detect clinical depression. We used this

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instrument as a baseline predictor and a secondary outcome variable, with assessments made at baseline, endpoint of treatment, and follow-up visits. 2.4. Treatment conditions 2.4.1. Cognitive Behavioral Therapy for Interoceptive Cues The CBT-IC treatment intervention was delivered in 12 individual weekly sessions and three booster sessions scheduled for 2 weeks, 1 month, and 2 months following completion of the protocol. The CBT-IC treatment combined four primary treatment components: an informational component, exposure to interoceptive (primarily emotional) cues of drug craving with rehearsal of adaptive responses, cognitive restructuring, and somatic coping skills. The informational component provided a review of behavioral patterns associated with drug craving and dependence, and a rationale for using the alternative responses to be learned in treatment. The interoceptive exposure component was based on procedures used in Panic Control Therapy (PCT) found to be effective in aiding benzodiazepine discontinuation (Otto et al., 1993), but was focused primarily on the emotional cues that increase drug craving. The goal of this emotional/interoceptive exposure procedure was to repeatedly expose patients to relevant emotional and somatic cues in order to reduce conditioned drug craving or drug use responses. Interoceptive exposure exercises were also used to rehearse adaptive behavioral alternatives as well as cognitive and somatic skills, to ensure that patients practiced applying self-control skills under conditions of interoceptive cues associated with craving and drug use. This novel treatment has similarities to both environmental cue exposure procedures (e.g., Franken et al., 1999) and coping skill treatment (Monti & O’Leary, 1999; Monti, Rohsenow, Michalec, Martin, & Abrams, 1997), but focuses on interoceptive rather than environmental cues and include intensive review of coping skills in this context. The cognitive component of treatment was treated both as an independent skill and an adjunct to the exposure procedures by focusing on strategies to modify maladaptive cognitions associated with interoceptive cues of craving. Modification of maladaptive cognitions included cognitive self-control procedures and cognitive-restructuring techniques. In addition, cognitive procedures were used in an attempt to maintain motivation during the discontinuation of illicit drugs, and as an intervention to aid in mood stability and stress reduction. The somatic skills included breathing retraining and muscle relaxation procedures. These procedures were targeted at helping patients reduce the intensity of physical sensations associated with withdrawal. In addition, these procedures were rehearsed in the context of interoceptive exposure as a means to provide patients with alternative, coping responses. A detailed treatment manual guided application of the treatment protocol.

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2.4.2. Enhanced treatment-as-usual To equate for therapist time in the CBT-IC condition, patients randomized to the TAU+ condition received an additional session of counseling for 12 weeks, plus three booster sessions scheduled at the same frequency as the CBT-IC sessions. The content of these therapy sessions was left unstructured, with the only instruction to the therapists being to continue their current strategies of treatment.

3. Results 3.1. Baseline characteristics Table 1 presents pre-treatment characteristics for participants. The CBT-IC and TAU+ conditions were comprised of 7 (58%) and 6 (55%) women, respectively. Eleven of 12 (92%) CBT-IC patients and 7 of 11 (64%) TAU+ patients were Caucasian; the remaining patients were 9% non-black Hispanic and 13% African American. The mean ( ± S.D.) age of participants was 39.5 ± 6.3 years for CBT-IC and 42.7 ± 5.7 years for TAU+ with no significant differences between groups in these demographic characteristics. The sample reported a mean of over two decades of substance abuse, with opiate and cocaine use the most common forms of ongoing, illicit drug use. Men had a significantly longer history of drug addiction than women (t = 8.87, df = 21, p < .01). High rates of current, comorbid psychiatric disorders were also evident, and there was evidence of higher psychological distress among women than men as indicated by the number of personality disorders on the PDQ-R (t = 2.25, df = 20, p < .04), higher HARS (t = 2.56, df = 21, p < .02), and HRSD scores (t = 2.75, df = 21, p < .02). Because of baseline

differences in distress indices, sex was included as a factor in all of the outcome analyses. 3.2. Treatment outcome Because random assignment did not fully equate groups, we evaluated the impact of treatment by examining differences between groups in the change in symptoms across treatment. Effect sizes (Cohen’s d) comparing differences between groups on these change scores were calculated using the following formula: d = {M(CBT-IC) M(TAU+)} / SD(pooled). These effect sizes, for secondary outcome variables, represent the average advantage of CBT-IC over TAU+ across the post-treatment period (averaging the results for the endpoint, month 1, month 2, and month 6 follow-up assessments). These effect-size computations were complemented by traditional significance testing, albeit at low power. For all analyses examining outcome we conducted intent-to-treat analyses, using the last observation carried forward as the best estimate. One patient assigned to CBT-IC dropped out immediately after randomization, and, consequently, data required for the objective measure of drug use (urine drug screens) for this patient could not be calculated and are not included in relevant analyses. To complement our conservative intent-to-treat analyses, we also provide information on the outcome of patients who achieved at least minimal participation in treatment (attending greater than 50% of the 12 weekly sessions). All 11 TAU+ patients met this criterion, as did 9 of 12 CBT-IC patients. Weekly urine drug screens allowed assessment of the percentage of drug screens that were negative for illicit substances. We selected two time periods by which to compute these percentages: early treatment (during the first

Table 1 Baseline drug use and psychiatric diagnosesa Women

Men

Treatment group TAU + Sample size Age (years) Methadone dose (mg) Duration of drug addiction (years) Number of drugs used Primary current drug of abuse Opiates Cocaine Benzodiazepines Marijuana Mood Disorders Anxiety Disorders Number of Personality Disordersb

6 43.5 75 24 2.2

± ± ± ±

Treatment group CBT-IC

3.7 24 5 .8

50 (3) 33 (2) 0 (0) 17 (1) 83 (5) 83 (5) 5.8 ± 2.6

7 36.0 75 17 2.0

± ± ± ±

TAU + 6.0 14 9 1.2

43 (3) 43 (3) 14 (1) 0 (0) 86 (6) 100 (7) 6.6 ± 2.8

Note: TAU+ = Enhanced Treatment-As-Usual; CBT-IC = Cognitive-Behavior Therapy for Interoceptive Cues. a Data are presented as percentage (number) or mean ± SD. b N = 22; 1 subject did not complete the Personality Disorders Questionnaire-Revised (PDQ-R). * Denotes significant difference between women and men ( p < .05). ** Denotes significant differences between women and men ( p < .01).

5 41.8 72 28 1.8

± ± ± ±

CBT-IC 7.9 21 9 .8

20 (1) 40 (2) 20 (1) 20 (1) 60 (3) 40 (2) 4.6 ± 2.1

5 44.4 56 31 2.0

± ± ± ±

1.5 35 4** .7

40 (2) 20 (1) 40 (2) 0 (0) 60 (3) 80 (4) 3.4 ± 2.1*

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8 weeks of treatment), and follow-up (over the full followup period, starting after the last regular session at week 12). For each patient, the percentage of negative urine assessments during the assessment period served as the outcome variable. There were no significant differences between the treatment groups for the number of screening evaluations available for assessment. For each time period we examined the Treatment  Sex main effects and interaction. No significant results were evident for the first two months of treatment (all p-values > .37), with no treatment group achieving more than 11% negative screening assessments. In the intent-to-treat analysis of the primary outcome measure, two female CBT-IC patients contributed a change score of zero due to missing data. Overall, there was an improvement in rates of negative drug screens over the course of subsequent treatment and follow-up, with a trend toward a Treatment  Sex interaction ( F(1, 18) = 3.01, p < .10). A follow-up analysis revealed that women treated with CBT-IC demonstrated a notable increase in the percent of drug-free urine screens relative to the TAU+ condition. The magnitude of this effect was medium to large (d = .61). Specifically, women receiving CBT-IC demonstrated a mean increase of 20% drug-free urine screenings, compared to 8% for women in the TAU+ group (see Fig. 1). For men, changes in the percentage of drug-free urine screens did not reach significance.

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However, there was a large effect size (d = .77) indicating that the intensification of TAU+ was superior to CBT-IC. Men in the TAU+ condition demonstrated a mean increase of 13% drug-free assessments compared to a mean decrease of 2% for men treated with CBT-IC. Despite the relatively small sample sizes, the impact of the different interventions in men and women appear to reflect general trends rather than unusual effects in a few outliers as illustrated in Fig. 2. Stronger findings emerged from the examination of those patients who completed at least a minimum ‘‘dose’’ of treatment (7 of the 12 weekly sessions). After week 12, there was a significant Treatment  Sex interaction ( F = 4.78; df = 1, 16; p < .05). CBT-IC was more effective for women (reflecting a very large effect size, d = 1.0), and again, men receiving a minimum ‘‘dose’’ of treatment achieved better outcome with TAU+ (d = .78). However, for the intent-to-treat sample this objective measure of substance use was only moderately correlated with the self-report item on drug difficulties on the ASI (r = .44, p < .04 at 1-month follow-up and r = .23, p = .31 at the 6-month follow-up). These results indicate at least a moderate disconnection between drug abstinence and the self-report of drug difficulties. For this secondary outcome measure of substance abuse, there were no significant differences between treatment conditions; nonetheless, examination of the relative benefit of the treatments with effect sizes indi-

Fig. 1. Percentage of negative illicit drug screens at each session for each treatment condition.

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Fig. 2. Percentage of negative illicit drug screens at each treatment phase for each treatment condition and patient.

cated an overall advantage for CBT-IC for men (mean effect size for week 12- through 6-month follow-up, d = .45), but a subtle disadvantage for women (d = .19) relative to TAU+. Alcohol abuse was generally low in the sample, particularly for women assigned to TAU+. Across treatment and follow-up, there were no significant differences between treatment conditions. Nonetheless, between-group analysis of changes in alcohol ASI scores indicated moderate effect sizes for women and subtle effect sizes for men (d = .37 and d = .13, respectively). These effects reflect a treatment advantage for CBT-IC relative to TAU+. There was a trend toward a significant interaction effect between treatment condition and sex on anxiety scores between symptoms at week 12 ( F = 3.46; df = 1, 19; p < .08). This interaction was significant at the 1-month followup ( F = 5.01; df = 1, 19; p < .05) indicating that CBT-IC was more effective than TAU+ for reducing anxiety in women. In contrast, treatment appeared to have a detrimental impact on levels of anxiety in men during these same assessment periods This effect was not well maintained across the follow-up assessments. At follow-up the average effect-size for the anxiety scores indicated a mean advantage of d = .74 for TAU+ for men, but only a subtle advantage of CBT-IC for women (d = .28).

At most of the assessments across treatment and followup, there were trends toward increasing depression scores. There were no significant treatment effects, but there was evidence for a greater worsening of symptoms for men receiving CBT-IC than TAU+ (d = .88), and a marginal advantage of d = .19 for CBT-IC for women. Scores for the drug outcome measures and affective distress were generally poorly correlated at follow-up (r values ranging from .38 to .23).

4. Discussion The CBT-IC program evaluated in this study was an outgrowth from cognitive-behavioral methods used to treat benzodiazepine dependence in patients with panic disorder (Otto et al., 1992, 1993). This treatment, CBT-IC, focused on: (a) helping opiate-dependent patients accept and tolerate negative emotional states and craving sensations: and (b) replacing drug-use responses to these emotions and sensations with alternative, adaptive behaviors. In this pilot study, we addressed the question of whether CBT-IC was more effective than an intensification of the existing program of counseling for patients failing to respond adequately to a

M.H. Pollack et al. / Journal of Substance Abuse Treatment 23 (2002) 335–342

treatment program. The answer to this question appears to be ‘‘yes,’’ but only for women. We found that on the objective measure of substance use — percentage of negative urine drug screens — our cognitive-behavioral program offered advantages to women who attended the treatment on the order of a very large (d = 1.00) effect size. Contrary to our expectations, we found that intensified counseling with existing providers tended to offer better outcome than CBTIC for men in our program (d = 0.89). It is not entirely clear why CBT-IC was effective for women only. There is limited evidence that negative mood induction may elicit stronger urges to use substances in women than in men (Monti, Rohsenow, Colby, & Abrams, 1995; Rubonis et al., 1994), and it is clear that, on average, women in the study were more distressed than the men. Although CBT-IC appeared to be more effective than counseling for reducing anxiety in women at endpoint, this was not the case for depressed mood, where there was no improvement from baseline for either treatment. Our data, indicating successful reductions in drug use in the context of only marginal changes in affective distress, suggest that CBT-IC may be breaking the link between negative affect and drug use. The link between affect and drug use was the intended target for our intervention, and the influence of sex on treatment effects is consistent with findings that this link is stronger in women than in men. This account of our findings is consistent with our clinical observations. In many cases women reported drug use as a strategy to dull emotional pain; whereas, it was more common for men to report drug use as a reward or as a way to enhance other tasks (e.g., ‘‘I only like going to a movie when I am high’’). These uncontrolled observations comport well with initial evidence on the role of sensationseeking in substance use, where sensation-seeking (adventure-seeking and relief from boredom) may play a more important role in the behavior of men than women (Beck, Thombs, Mahoney, & Fingar, 1995). Moreover, the role of sensation-seeking in substance use appears to be diminished when anxiety problems are present (Scourfield, Stevens, & Merikangas, 1996) as was characteristic of our sample of women. Accordingly, in future research we will examine the significance of emotional avoidance compared to sensationseeking as a motive for illicit drug use in predicting response to CBT-IC. In our study, objective levels of drug use did not correlate with subjective reports on the ASI, although support for the relative efficacy of CBT-IC on the order of a small effect size (d = .25) was evident on the alcohol subscale of the ASI. Our data underscore the importance of objective measures in substance dependence research. Our study suffers from the methodological limitations inherent in any pilot project, including the need to rely on effect size estimates rather than significance testing to understand the impact of treatment comparisons. Although effect size estimates from smaller studies may be somewhat volatile, our results for our objective and primary outcomes were

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suggestive of strong effects for a novel approach to a treatment-resistant sample. In summary, results from this small study must be considered as provisional, but our findings do encourage further examination of this treatment and its underlying mechanism. In particular, our results suggest that attention to the modification of drug-use responses to affective cues may be a fruitful approach, and should be considered as a promising complement to more traditional approaches that attend to external context as cues for use.

Acknowledgments The authors wish to thank the staff and management of Habit Management Institute whose support made completion of this project possible. This project was supported by a grant to Dr. Pollack from the National Institute of Drug Abuse (R-21, #DA10040-02).

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