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Impact of lisdexamfetamine on retention of methamphetamine-dependent patients in a residential facility
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Abstracts / Drug and Alcohol Dependence 171 (2017) e2–e226
ships. There was a significant treatment effect on change (ˇ = .523; p < 0.05) in CO levels, but no significant effect on change SU, where those in the treatment group had more of a decrease in CO levels than those in the placebo group. Conclusions: The relationship between cigarette smoking and SU remains high, though the two are rarely treated simultaneously. While these findings are in line with the original findings reported, it is important for treatment researchers to understand and better optimize how treatment of one disorder can have an impact on secondary targeted disorders. Financial support: National Drug Abuse Treatment Clinical Trials Network Pacific Northwest Node (U10DA013714). http://dx.doi.org/10.1016/j.drugalcdep.2016.08.354 Impact of lisdexamfetamine on retention of methamphetamine-dependent patients in a residential facility Michael J. Mancino 1,∗ , Jeff D. Thostenson 2 , J. Benjamin Guise 1 , Janette McGaugh 1 , Alison Oliveto 1 1
Psychiatry, University of Arkansas for Medical Sciences, Little Rock, AR, United States 2 Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, United States Aims: Determine whether baseline characteristics predict retention and whether retention differed between placebo (PLA) vs. lisdexamfetamine (LDX) (140 mg/day) during the 8-day residential stay in a 9-wk, double blind, placebo-controlled clinical trial. Methods: Methamphetamine (MA) dependent participants were placed in research beds at a residential treatment facility and randomized by sex, nicotine use, severity of dependence and childhood diagnosis of ADHD to receive either LDX (N = 5) or placebo (N = 5). Participants participated in the Substance Abuse Day Treatment Program during their stay. Baseline characteristics and assessments (ADHD Rating scale, Barratt Impulsivity Score, VAS craving, and HAM-A/D) were examined to determine whether these predicted successful completion of the 8-day residential treatment. Results: Thus far, 13 subjects have been enrolled in the study protocol, of which 10 received study medication and 5 completed the first week of treatment. Reasons for dropout prior to the end of the residential stay include: split treatment (N = 7), noncompliance with facility rules (N = 1) and vitals outside of dosing parameters (N = 1). Med groups did not differ on any of the baseline characteristics. No baseline measures predict successful completion of the first week of treatment at this point in time. However, there was a trend toward patients in the PLA group completing a longer period in the study than the LDX group (4.83 ± 3.92 vs. 0.74 ± 0.75 weeks; p = 0.08). Conclusions: These very preliminary results suggest that LDX may not be efficacious for treating methamphetamine dependence. Although these findings are limited by the high dropout rate, this poor retention rate reflects a significant issue with this patient population, highlighting the importance of identifying pharmacotherapies that enhance retention. Financial support: Supported by grants DA034824-02, P30 GM110702. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.355
“The devil I know is better than the devil I don’t know”: Enrollment in a pilot trial of opioid dose escalation vs. buprenorphine/naloxone for pain Ajay Manhapra ∗ , David A. Fiellin, William Becker Yale University, New Haven, CT, United States Aims: Harms related to opioid therapy prescribed for chronic pain are increasing and appear to be dose related. Although buprenorphine/naloxone (BUP/NX) may be a safer alternative to opioid dose escalation among patients having uncontrolled pain while on moderate dose of opioids (30–100 oral morphine equivalents [OME] per day) for chronic pain, its acceptability is not known. Our aim was to determine the acceptability of enrolling in a trial of BUP/NX vs. opioid dose escalation among patients receiving opioids for chronic pain whose pain is not well controlled. Methods: We tried recruiting patients who were ≥21 years of age, prescribed 30–100 MEQ/day of opioids for pain for ≥3 months, and had pain score ≥4/10 on numeric scale or ≥28/70 on Brief Pain Inventory. A physician with expertise in pain and addiction discussed the trial with eligible patients by telephone. If they did not agree to participate, they were asked why not. Results: We approached 114 eligible patients (mean age of 65.3 years [SD 10.1], 95.6% male, 85.1% Whites, and mean opioid dose of 64.6 OME/day [SD 18.6]). Only 8 patients (7%) who were dissatisfied with their pain control agreed to enroll in the study. Among the 106 patients who did not enroll, 12% were open to the idea of an alternate medication, but unwilling to make a change, and 18% were not interested in new medication despite dissatisfaction with pain control on their current opioid regimen, with one patient offering the representative quote “The devil I know is better than the devil I don’t know”. Four (3.77%) deferred recruitment to get second opinion from their primary care providers, and 52% opted out, did not return call or did not provide a reason. Logistical difficulties to participate in the study were provided as reason by 14.15%, and one patient was excluded as he was starting to engage in substance abuse treatment. Conclusions: Lack of familiarity with the medication may hinder attempts to transfer patients prescribed full agonists for pain to BUP/NX. Financial support: Ajay Manhapra was supported by Research in Addiction Medicine Scolars Program. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.356 Physical health of women recovering from prescription opioid abuse Katherine R. Marks ∗ , Melissa Delaney, Carl Leukefeld Behavioral Science, University of Kentucky, Lexington, KY, United States Aims: The existing literature has primarily described the negative consequences of prescription opioid abuse on physical health and chronic pain management in women. Recovery-oriented research represents a paradigm shift by focusing on wellness and constructive, strength-based assets. The aim of this study was to understand how women’s physical health is associated with engaging in behavioral change to reduce prescription opioid abuse. Methods: This study used self-reported interview data from Kentucky’s Targeted Assessment Program (TAP). TAP provides assessments, pre-treatment, and referral to community treatment for problems that impede transitioning from welfare to work and/or interfere with parental responsibilities. Data included 1204 women over the age of 18 who reported their prescription opioid abuse as
Abstracts / Drug and Alcohol Dependence 171 (2017) e2–e226
ships. There was a significant treatment effect on change (ˇ = .523; p < 0.05) in CO levels, but no significant effect on change SU, where those in the treatment group had more of a decrease in CO levels than those in the placebo group. Conclusions: The relationship between cigarette smoking and SU remains high, though the two are rarely treated simultaneously. While these findings are in line with the original findings reported, it is important for treatment researchers to understand and better optimize how treatment of one disorder can have an impact on secondary targeted disorders. Financial support: National Drug Abuse Treatment Clinical Trials Network Pacific Northwest Node (U10DA013714). http://dx.doi.org/10.1016/j.drugalcdep.2016.08.354 Impact of lisdexamfetamine on retention of methamphetamine-dependent patients in a residential facility Michael J. Mancino 1,∗ , Jeff D. Thostenson 2 , J. Benjamin Guise 1 , Janette McGaugh 1 , Alison Oliveto 1 1
Psychiatry, University of Arkansas for Medical Sciences, Little Rock, AR, United States 2 Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, United States Aims: Determine whether baseline characteristics predict retention and whether retention differed between placebo (PLA) vs. lisdexamfetamine (LDX) (140 mg/day) during the 8-day residential stay in a 9-wk, double blind, placebo-controlled clinical trial. Methods: Methamphetamine (MA) dependent participants were placed in research beds at a residential treatment facility and randomized by sex, nicotine use, severity of dependence and childhood diagnosis of ADHD to receive either LDX (N = 5) or placebo (N = 5). Participants participated in the Substance Abuse Day Treatment Program during their stay. Baseline characteristics and assessments (ADHD Rating scale, Barratt Impulsivity Score, VAS craving, and HAM-A/D) were examined to determine whether these predicted successful completion of the 8-day residential treatment. Results: Thus far, 13 subjects have been enrolled in the study protocol, of which 10 received study medication and 5 completed the first week of treatment. Reasons for dropout prior to the end of the residential stay include: split treatment (N = 7), noncompliance with facility rules (N = 1) and vitals outside of dosing parameters (N = 1). Med groups did not differ on any of the baseline characteristics. No baseline measures predict successful completion of the first week of treatment at this point in time. However, there was a trend toward patients in the PLA group completing a longer period in the study than the LDX group (4.83 ± 3.92 vs. 0.74 ± 0.75 weeks; p = 0.08). Conclusions: These very preliminary results suggest that LDX may not be efficacious for treating methamphetamine dependence. Although these findings are limited by the high dropout rate, this poor retention rate reflects a significant issue with this patient population, highlighting the importance of identifying pharmacotherapies that enhance retention. Financial support: Supported by grants DA034824-02, P30 GM110702. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.355
“The devil I know is better than the devil I don’t know”: Enrollment in a pilot trial of opioid dose escalation vs. buprenorphine/naloxone for pain Ajay Manhapra ∗ , David A. Fiellin, William Becker Yale University, New Haven, CT, United States Aims: Harms related to opioid therapy prescribed for chronic pain are increasing and appear to be dose related. Although buprenorphine/naloxone (BUP/NX) may be a safer alternative to opioid dose escalation among patients having uncontrolled pain while on moderate dose of opioids (30–100 oral morphine equivalents [OME] per day) for chronic pain, its acceptability is not known. Our aim was to determine the acceptability of enrolling in a trial of BUP/NX vs. opioid dose escalation among patients receiving opioids for chronic pain whose pain is not well controlled. Methods: We tried recruiting patients who were ≥21 years of age, prescribed 30–100 MEQ/day of opioids for pain for ≥3 months, and had pain score ≥4/10 on numeric scale or ≥28/70 on Brief Pain Inventory. A physician with expertise in pain and addiction discussed the trial with eligible patients by telephone. If they did not agree to participate, they were asked why not. Results: We approached 114 eligible patients (mean age of 65.3 years [SD 10.1], 95.6% male, 85.1% Whites, and mean opioid dose of 64.6 OME/day [SD 18.6]). Only 8 patients (7%) who were dissatisfied with their pain control agreed to enroll in the study. Among the 106 patients who did not enroll, 12% were open to the idea of an alternate medication, but unwilling to make a change, and 18% were not interested in new medication despite dissatisfaction with pain control on their current opioid regimen, with one patient offering the representative quote “The devil I know is better than the devil I don’t know”. Four (3.77%) deferred recruitment to get second opinion from their primary care providers, and 52% opted out, did not return call or did not provide a reason. Logistical difficulties to participate in the study were provided as reason by 14.15%, and one patient was excluded as he was starting to engage in substance abuse treatment. Conclusions: Lack of familiarity with the medication may hinder attempts to transfer patients prescribed full agonists for pain to BUP/NX. Financial support: Ajay Manhapra was supported by Research in Addiction Medicine Scolars Program. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.356 Physical health of women recovering from prescription opioid abuse Katherine R. Marks ∗ , Melissa Delaney, Carl Leukefeld Behavioral Science, University of Kentucky, Lexington, KY, United States Aims: The existing literature has primarily described the negative consequences of prescription opioid abuse on physical health and chronic pain management in women. Recovery-oriented research represents a paradigm shift by focusing on wellness and constructive, strength-based assets. The aim of this study was to understand how women’s physical health is associated with engaging in behavioral change to reduce prescription opioid abuse. Methods: This study used self-reported interview data from Kentucky’s Targeted Assessment Program (TAP). TAP provides assessments, pre-treatment, and referral to community treatment for problems that impede transitioning from welfare to work and/or interfere with parental responsibilities. Data included 1204 women over the age of 18 who reported their prescription opioid abuse as