- Email: [email protected]
Impact of recovery interventions on opioid users. A simulation study
Abstracts / Drug and Alcohol Dependence 171 (2017) e2–e226
sitivity to change. Notably, there was an average of 15 items or 9 min to complete each CAT, significantly lower (p = 0.0002) than the original version. Conclusions: The IRT-calibrated ASI-MV CATs show promise as enhanced versions of the traditional ASI composite scores, and provide further evidence that adaptive testing based on IRT modeling could prove useful in developing highly precise measurement in the areas of addiction and mental health more broadly, as has been demonstrated in the educational field. Financial support: NIDA Grant No. R44A023322. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.071 The role of genetic polymorphisms on patient response to opioid use disorder therapy with naltrexone and guanfacine Elena Blokhina 1,∗ , Evgeny Krupitsky 1,4 , Alexander Kibitov 3 , Elena Verbitskaya 1 , Thomas Kosten 2 , David A. Nielsen 2 , Edwin Zvartau 1 1
First Pavlov State Medical University, St. Petersburg, Russian Federation 2 Baylor College of Medicine, Houston, TX, United States 3 Serbsky Federal Medical Research Centre of Psychiatry and Narcology, Moscow, Russian Federation 4 Bekhterev Research Psychoneurological Institute, St. Petersburg, Russian Federation
Aims: The study was designed to evaluate the moderation of opioid receptor and dopamine system gene polymorphisms on treatment outcomes of the pharmacotherapy of opioid use disorder with oral naltrexone and guanfacine in a randomized placebocontrolled clinical trial. Methods: 301 patients with opioid dependence were randomized into four treatment groups: naltrexone, 50 mg/day + guanfacine, 1 mg/day (N + G); naltrexone + placebo (N + GP); placebo + guanfacine (NP + G); and double placebo (NP + GP). All participants provided a blood sample for genetic analysis of polymorphisms in the mu- (OPRM1) and kappa-opioid (OPRK1) receptors, dopamine type 2 (DRD2) and 4 (DRD4) receptors, and dopamine-beta-hydroxylase (DBH) genes. Results: Regardless of the treatment provided, several alleles were associated with a higher chance to complete the treatment program: DRD4 C-521T (rs1800955) T allele (p = 0.039; OR (95%CI) = 3.7 (1.1–12.7); log-rank test: p = 0.01); DRD2 C957T (rs6277) C allele (p = 0.03; HR = 0.6 (0.34–0.95); as well as a combination of genotypes: DRD2 C957T (TT) + OPRM1 (rs1074287) (CC), p = 0.025; DRD2-141C (II) + OPRM1 (rs510769) (AA), p = 0.035; DBH 1021C/T (rs1611115) (CC) + OPRM1 (rs1074287) (CC), p = 0.05. The associations were dependent on the treatment group: (1) patients in the N + G group with the DRD4 C-521T TT genotype had a higher probability of treatment program completion (log-rank test: p = 0.002); (2) patients in NP + GP group who were carriers of the OPRM1 rs510769 T allele of had a higher risk of relapse compare to GG genotype patients (p = 0.008) (FDR p < 0.0125). Conclusions: The study showed joint moderation of both opioid receptor and dopaminergic system genes on the treatment outcomes of opioid use disorder with oral naltrexone and guanfacine. Financial support: R01DA018863-04.
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Changes in quality of life in cocaine-dependent participants provided treatment with buprenorphine + naloxone & extended release naltrexone Dikla Blumberg 1,∗ , Fermin Carrizales 2 , William Kazanis 2 , Maureen P. Hillhouse 3 , Abigail G. Matthews 4 , Jennifer Sharpe Potter 2 1 NIDA Clinical Coordinating Center, The Emmes Corporation, Rockville, MD, United States 2 Psychiatry, UT Health Science Center, San Antonio, TX, United States 3 Integrated Substance Abuse Programs, University of California, Los Angeles, CA, United States 4 The Emmes Corporation, Rockville, MD, United States
Aims: Quality of life is an important construct in assessing outcomes of substance use treatment interventions. The goal of the current analysis was to evaluate changes in participants’ quality of life in the Clinical Trials Network multi-site Cocaine Use Reduction with Buprenorphine (CURB) study in cocaine-dependent opioid users. Methods: Participants were randomly assigned to 1 of 3 conditions provided with extended-release naltrexone: 16 mg/day buprenorphine + naloxone (BUP) (BUP16), 4 mg/day BUP (BUP4), 0 mg/day BUP (placebo, PLB), plus weekly therapy. Participants completed the WHOQOL-BREF at screening, end of medication/treatment, and the 3-month follow up. This 24-item measure assessed quality of life across physical, psychological, social, and environmental domains. Results: Of the 302 study participants, 219 completed QOL surveys at all time points and were used in the analyses. Baseline Quality of Life scores were lower than the norms established for individuals in a healthy population in all domains. No treatment effects were found, but there were statistically significant differences in mean ratings of QOL across the time points in all domains: Physical (F (2, 432) = 40.93, p < .001), Psychological (F (2, 432) = 40.32, p < .001), Social, (F (2, 432) = 25.91, p < .001) and Environmental (F (2, 432) = 46.05, p < .001). Despite the significant increase in QOL at end of treatment, compared to the general population participants were still scoring low in Social and Environmental domains. Conclusions: The results showed significant improvements in quality of life between the start and end of treatment. However, despite the improvement participants remained considerably lower than healthy population norms across some domains, suggesting the particular vulnerability of this substance using population. Financial support: HHSN271201000024C. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.073 Impact of recovery interventions on opioid users. A simulation study Georgiy Bobashev 1,∗ , Barry Eggleston 1 , Robert J. Morris 1 , Carolina Barbosa 1 , William Dowd 1 , Michael L. Dennis 2 , Christy K. Scott 2 1 2
RTI International, Durham, NC, United States Chestnut, Chicago, IL, United States
http://dx.doi.org/10.1016/j.drugalcdep.2016.08.072 Aims: (1) To characterize life trajectories for opioid users transitioning between 12 mutually exclusive states that capture opioid
e22
Abstracts / Drug and Alcohol Dependence 171 (2017) e2–e226
recovery process. The states are characterized by a combination of use status, location (being in community, jail, special residence), being in treatment, being under criminal justice supervision; (2) to project the impact of continuum of services and community support interventions on life trajectories of opioid users. Methods: Developed a microsimulation model that considers a cohort of opioid users being in treatment at baseline. Individuals move between 12 mutually exclusive states. The transition probabilities were estimated using an innovative Bayesian approach that combined published peer-reviewed literature with the estimates from the GAIN data. The GAIN sample contained 979 unique opioid users providing at least two consecutive responses during their baseline, 3-, 6- and 12-month assessments. Transition depended on age, sex, number of convictions and treatment episodes. Parameter values corresponding to the intervention effects were obtained from peer-reviewed literature. Results: The analysis of simulated trajectories showed that the results of each: the continuity of services and community support intervention were moderate. In a long-term (5-year) simulation most important cohort statistics (percent incarcerated, percent non-using, percent using in the community, etc.) have improved by 10%. An extreme hypothetical case of a powerful continuum of services intervention which reached the odds ratios of 10 and 5 has resulted in the increase of 50% in percent in recovery. Conclusions: Recovery-focused interventions should consider multiple states and state transitions in the users’ life trajectories. Multiple interventions (such as continuum of services, and community support) are needed to achieve substantial reduction in use and the increase the percent of users in recovery. Validation analysis shows a strong heterogeneity in life trajectories across different populations. Financial support: Funded by NIDA R21 grant 5R21DA32670. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.074 Acceptability and feasibility of an intervention for overdose and HIV risk during addictions treatment for patients with prescription opioid misuse Amy S.B. Bohnert ∗ , Maureen Walton, Frederic Blow, Laura Thomas, Mark llgen Psychiatry, University of Michigan, Ann Arbor, MI, United States Aims: Prescription opioid overdose and HIV represent two highly critical public health problems related to substance use. The period after addictions treatment is particularly high risk for overdose; further, overdose and HIV share some behavioral risk factors. The purpose of this study was to examine the acceptability and feasibility of an overdose and HIV risk behavior intervention delivered during residential addictions treatment. Methods: Data were collected during a pilot clinical trial conducted at a single residential addictions program in Michigan. Eligibility included at least moderate prescription opioid misuse before treatment. Groups of men and women were randomized to receive either an intervention or attention educational control condition; both consisted of two group and one individual session. The intervention used a motivational interviewing approach. Results: 94% of 62 intervention and 64 educational control participants attended all 3 sessions. Attendance did not differ by group (p = .5). Participants in both groups gave similarly high ratings for the likeability and helpfulness of the sessions. For example, no participants rated the likeability of the group sessions as negatively or neutrally; 67% in each group rated it at the highest
level. Similarly, 79% of control participants and 86% of intervention participants found the therapist’s guidance during the group sessions as “Very helpful” (p = .34). Similar patterns were observed for the individual sessions. Based on a summary score of 3 items assessing self-efficacy to reduce overdose risk, both intervention and control participants reported significant increases (p < .05) in self-efficacy between baseline and post-intervention (mean change 2.89 in intervention and 2.52 in control, no difference between groups). Conclusions: This study establishes the feasibility and acceptability of this intervention as well as a comparison condition. Future research will examine behavioral outcomes and health status after treatment. Financial support: NIH R34 DA035331. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.075 Properties of the marijuana motives questionnaire among medical cannabis patients Kipling Bohnert 2,1,∗ , Mark Ilgen 2,1 1 Psychiatry, University of Michigan, Ann Arbor, MI, United States 2 VA Center for Clinical Management Research, Ann Arbor, MI, United States
Aims: Although 23 States and the District of Columbia have passed legislation allowing for the use of cannabis for those with qualifying medical conditions, the understanding of medical cannabis patients is limited. In particular, little research has evaluated motives for cannabis use among this population. In this study, we evaluate the properties of the 12-factor, 36-item Marijuana Motives Questionnaire (MMQ) developed by Lee et al. (2009) in a sample of medical cannabis patients. Methods: Potential study participants were adult patients (≥21 years old) with a scheduled appointment to obtain medical cannabis certification for the first time or to renew an existing medical cannabis card. Patients were approached by research assistants (RAs) in clinic waiting areas. RAs provided a brief overview of the study and obtained written informed consent for screening. Consenting participants completed a 20–30 min self-administered screening survey on either a touchscreen web-based tablet computer or on paper. The present study consisted of all those in the screening sample who had complete data on the MMQ (n = 1191). Confirmatory factor analysis via SAS Proc CALIS was used to evaluate properties of the MMQ in the sample. Results: Fit indices were acceptable, and as follows: the root mean square error of approximation (RMSEA) estimate was 0.054 (90% Confidence Limit 0.052–0.056); the Comparative Fit Index (CFI) was 0.923. The internal consistencies of the 12 factors were good to excellent, and as follows: 0.65 (Conformity); 0.77 (Coping); 0.79 (Enjoyment); 0.79 (Experimentation); 0.80 (Availability); 0.82 (Sleep); .84 (Relative Low Risk); 0.85 (Social Anxiety); 0.84 (Boredom); 0.88 (Altered Perception); 0.89 (Alcohol); 0.92 (Celebration). Conclusions: In this sample of medical cannabis patients, the MMQ performed similarly to samples of individuals using cannabis recreationally. Individuals using cannabis for medical conditions may have diverse reasons for use. Financial support: R01 DA033397. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.076
sitivity to change. Notably, there was an average of 15 items or 9 min to complete each CAT, significantly lower (p = 0.0002) than the original version. Conclusions: The IRT-calibrated ASI-MV CATs show promise as enhanced versions of the traditional ASI composite scores, and provide further evidence that adaptive testing based on IRT modeling could prove useful in developing highly precise measurement in the areas of addiction and mental health more broadly, as has been demonstrated in the educational field. Financial support: NIDA Grant No. R44A023322. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.071 The role of genetic polymorphisms on patient response to opioid use disorder therapy with naltrexone and guanfacine Elena Blokhina 1,∗ , Evgeny Krupitsky 1,4 , Alexander Kibitov 3 , Elena Verbitskaya 1 , Thomas Kosten 2 , David A. Nielsen 2 , Edwin Zvartau 1 1
First Pavlov State Medical University, St. Petersburg, Russian Federation 2 Baylor College of Medicine, Houston, TX, United States 3 Serbsky Federal Medical Research Centre of Psychiatry and Narcology, Moscow, Russian Federation 4 Bekhterev Research Psychoneurological Institute, St. Petersburg, Russian Federation
Aims: The study was designed to evaluate the moderation of opioid receptor and dopamine system gene polymorphisms on treatment outcomes of the pharmacotherapy of opioid use disorder with oral naltrexone and guanfacine in a randomized placebocontrolled clinical trial. Methods: 301 patients with opioid dependence were randomized into four treatment groups: naltrexone, 50 mg/day + guanfacine, 1 mg/day (N + G); naltrexone + placebo (N + GP); placebo + guanfacine (NP + G); and double placebo (NP + GP). All participants provided a blood sample for genetic analysis of polymorphisms in the mu- (OPRM1) and kappa-opioid (OPRK1) receptors, dopamine type 2 (DRD2) and 4 (DRD4) receptors, and dopamine-beta-hydroxylase (DBH) genes. Results: Regardless of the treatment provided, several alleles were associated with a higher chance to complete the treatment program: DRD4 C-521T (rs1800955) T allele (p = 0.039; OR (95%CI) = 3.7 (1.1–12.7); log-rank test: p = 0.01); DRD2 C957T (rs6277) C allele (p = 0.03; HR = 0.6 (0.34–0.95); as well as a combination of genotypes: DRD2 C957T (TT) + OPRM1 (rs1074287) (CC), p = 0.025; DRD2-141C (II) + OPRM1 (rs510769) (AA), p = 0.035; DBH 1021C/T (rs1611115) (CC) + OPRM1 (rs1074287) (CC), p = 0.05. The associations were dependent on the treatment group: (1) patients in the N + G group with the DRD4 C-521T TT genotype had a higher probability of treatment program completion (log-rank test: p = 0.002); (2) patients in NP + GP group who were carriers of the OPRM1 rs510769 T allele of had a higher risk of relapse compare to GG genotype patients (p = 0.008) (FDR p < 0.0125). Conclusions: The study showed joint moderation of both opioid receptor and dopaminergic system genes on the treatment outcomes of opioid use disorder with oral naltrexone and guanfacine. Financial support: R01DA018863-04.
e21
Changes in quality of life in cocaine-dependent participants provided treatment with buprenorphine + naloxone & extended release naltrexone Dikla Blumberg 1,∗ , Fermin Carrizales 2 , William Kazanis 2 , Maureen P. Hillhouse 3 , Abigail G. Matthews 4 , Jennifer Sharpe Potter 2 1 NIDA Clinical Coordinating Center, The Emmes Corporation, Rockville, MD, United States 2 Psychiatry, UT Health Science Center, San Antonio, TX, United States 3 Integrated Substance Abuse Programs, University of California, Los Angeles, CA, United States 4 The Emmes Corporation, Rockville, MD, United States
Aims: Quality of life is an important construct in assessing outcomes of substance use treatment interventions. The goal of the current analysis was to evaluate changes in participants’ quality of life in the Clinical Trials Network multi-site Cocaine Use Reduction with Buprenorphine (CURB) study in cocaine-dependent opioid users. Methods: Participants were randomly assigned to 1 of 3 conditions provided with extended-release naltrexone: 16 mg/day buprenorphine + naloxone (BUP) (BUP16), 4 mg/day BUP (BUP4), 0 mg/day BUP (placebo, PLB), plus weekly therapy. Participants completed the WHOQOL-BREF at screening, end of medication/treatment, and the 3-month follow up. This 24-item measure assessed quality of life across physical, psychological, social, and environmental domains. Results: Of the 302 study participants, 219 completed QOL surveys at all time points and were used in the analyses. Baseline Quality of Life scores were lower than the norms established for individuals in a healthy population in all domains. No treatment effects were found, but there were statistically significant differences in mean ratings of QOL across the time points in all domains: Physical (F (2, 432) = 40.93, p < .001), Psychological (F (2, 432) = 40.32, p < .001), Social, (F (2, 432) = 25.91, p < .001) and Environmental (F (2, 432) = 46.05, p < .001). Despite the significant increase in QOL at end of treatment, compared to the general population participants were still scoring low in Social and Environmental domains. Conclusions: The results showed significant improvements in quality of life between the start and end of treatment. However, despite the improvement participants remained considerably lower than healthy population norms across some domains, suggesting the particular vulnerability of this substance using population. Financial support: HHSN271201000024C. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.073 Impact of recovery interventions on opioid users. A simulation study Georgiy Bobashev 1,∗ , Barry Eggleston 1 , Robert J. Morris 1 , Carolina Barbosa 1 , William Dowd 1 , Michael L. Dennis 2 , Christy K. Scott 2 1 2
RTI International, Durham, NC, United States Chestnut, Chicago, IL, United States
http://dx.doi.org/10.1016/j.drugalcdep.2016.08.072 Aims: (1) To characterize life trajectories for opioid users transitioning between 12 mutually exclusive states that capture opioid
e22
Abstracts / Drug and Alcohol Dependence 171 (2017) e2–e226
recovery process. The states are characterized by a combination of use status, location (being in community, jail, special residence), being in treatment, being under criminal justice supervision; (2) to project the impact of continuum of services and community support interventions on life trajectories of opioid users. Methods: Developed a microsimulation model that considers a cohort of opioid users being in treatment at baseline. Individuals move between 12 mutually exclusive states. The transition probabilities were estimated using an innovative Bayesian approach that combined published peer-reviewed literature with the estimates from the GAIN data. The GAIN sample contained 979 unique opioid users providing at least two consecutive responses during their baseline, 3-, 6- and 12-month assessments. Transition depended on age, sex, number of convictions and treatment episodes. Parameter values corresponding to the intervention effects were obtained from peer-reviewed literature. Results: The analysis of simulated trajectories showed that the results of each: the continuity of services and community support intervention were moderate. In a long-term (5-year) simulation most important cohort statistics (percent incarcerated, percent non-using, percent using in the community, etc.) have improved by 10%. An extreme hypothetical case of a powerful continuum of services intervention which reached the odds ratios of 10 and 5 has resulted in the increase of 50% in percent in recovery. Conclusions: Recovery-focused interventions should consider multiple states and state transitions in the users’ life trajectories. Multiple interventions (such as continuum of services, and community support) are needed to achieve substantial reduction in use and the increase the percent of users in recovery. Validation analysis shows a strong heterogeneity in life trajectories across different populations. Financial support: Funded by NIDA R21 grant 5R21DA32670. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.074 Acceptability and feasibility of an intervention for overdose and HIV risk during addictions treatment for patients with prescription opioid misuse Amy S.B. Bohnert ∗ , Maureen Walton, Frederic Blow, Laura Thomas, Mark llgen Psychiatry, University of Michigan, Ann Arbor, MI, United States Aims: Prescription opioid overdose and HIV represent two highly critical public health problems related to substance use. The period after addictions treatment is particularly high risk for overdose; further, overdose and HIV share some behavioral risk factors. The purpose of this study was to examine the acceptability and feasibility of an overdose and HIV risk behavior intervention delivered during residential addictions treatment. Methods: Data were collected during a pilot clinical trial conducted at a single residential addictions program in Michigan. Eligibility included at least moderate prescription opioid misuse before treatment. Groups of men and women were randomized to receive either an intervention or attention educational control condition; both consisted of two group and one individual session. The intervention used a motivational interviewing approach. Results: 94% of 62 intervention and 64 educational control participants attended all 3 sessions. Attendance did not differ by group (p = .5). Participants in both groups gave similarly high ratings for the likeability and helpfulness of the sessions. For example, no participants rated the likeability of the group sessions as negatively or neutrally; 67% in each group rated it at the highest
level. Similarly, 79% of control participants and 86% of intervention participants found the therapist’s guidance during the group sessions as “Very helpful” (p = .34). Similar patterns were observed for the individual sessions. Based on a summary score of 3 items assessing self-efficacy to reduce overdose risk, both intervention and control participants reported significant increases (p < .05) in self-efficacy between baseline and post-intervention (mean change 2.89 in intervention and 2.52 in control, no difference between groups). Conclusions: This study establishes the feasibility and acceptability of this intervention as well as a comparison condition. Future research will examine behavioral outcomes and health status after treatment. Financial support: NIH R34 DA035331. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.075 Properties of the marijuana motives questionnaire among medical cannabis patients Kipling Bohnert 2,1,∗ , Mark Ilgen 2,1 1 Psychiatry, University of Michigan, Ann Arbor, MI, United States 2 VA Center for Clinical Management Research, Ann Arbor, MI, United States
Aims: Although 23 States and the District of Columbia have passed legislation allowing for the use of cannabis for those with qualifying medical conditions, the understanding of medical cannabis patients is limited. In particular, little research has evaluated motives for cannabis use among this population. In this study, we evaluate the properties of the 12-factor, 36-item Marijuana Motives Questionnaire (MMQ) developed by Lee et al. (2009) in a sample of medical cannabis patients. Methods: Potential study participants were adult patients (≥21 years old) with a scheduled appointment to obtain medical cannabis certification for the first time or to renew an existing medical cannabis card. Patients were approached by research assistants (RAs) in clinic waiting areas. RAs provided a brief overview of the study and obtained written informed consent for screening. Consenting participants completed a 20–30 min self-administered screening survey on either a touchscreen web-based tablet computer or on paper. The present study consisted of all those in the screening sample who had complete data on the MMQ (n = 1191). Confirmatory factor analysis via SAS Proc CALIS was used to evaluate properties of the MMQ in the sample. Results: Fit indices were acceptable, and as follows: the root mean square error of approximation (RMSEA) estimate was 0.054 (90% Confidence Limit 0.052–0.056); the Comparative Fit Index (CFI) was 0.923. The internal consistencies of the 12 factors were good to excellent, and as follows: 0.65 (Conformity); 0.77 (Coping); 0.79 (Enjoyment); 0.79 (Experimentation); 0.80 (Availability); 0.82 (Sleep); .84 (Relative Low Risk); 0.85 (Social Anxiety); 0.84 (Boredom); 0.88 (Altered Perception); 0.89 (Alcohol); 0.92 (Celebration). Conclusions: In this sample of medical cannabis patients, the MMQ performed similarly to samples of individuals using cannabis recreationally. Individuals using cannabis for medical conditions may have diverse reasons for use. Financial support: R01 DA033397. http://dx.doi.org/10.1016/j.drugalcdep.2016.08.076