ABSTRACT

1. Baseline Characteristics by Primary Substance of Abuse of Outpatient Clients in a Web-based Intervention Trial • Aimee N. C. Campbell, Ph.D.1,2,3, Edward V. Nunes, M.D.1,3 , Mei-Chen Hu, Ph.D. 3, Gloria M. Miele, Ph.D.1, Martina Pavlicova, Ph.D. 4 • New York State Psychiatric Institute (2) St. Luke’s-Roosevelt Hospital (3) Columbia University College of Physicians & Surgeons, Department of Psychiatry (4) Columbia University Medical Center, Department of Biostatistics DISCUSSION ABSTRACT RESULTS • This innovative, computer-assisted intervention trial attracted and recruited a diverse substance using sample in the first few weeks of their treatment episode. The majority of clients were ineligible due to a lack of illicit substance use in the prior 30 days, highlighting a common finding of reduced use prior to treatment. • The fact that the intervention was web-based did not seem to deter clients from participating, a positive finding for this new technology. • There were surprisingly few significant differences in demographic or clinical characteristics by primary substance. • Marijuana and opiate users were younger than alcohol, cocaine, and other stimulant users. The opiate finding is likely fueled by prescription opiate abuse. Further, the vast majority of opiate users identified as White, while the majority of cocaine users identified as African American. • There were high rates of 12-step attendance, especially for clients newly enrolled in treatment; the exception being lower rates among marijuana users. Marijuana users may require alternative ancillary support services. • Participants also had relatively high rates of depressive symptoms and nicotine use, though these did not differ by primary substance. • Of note, sexual risk (both unprotected sex acts and proportion of sex acts that were unprotected-findings not reported in the table) was not significantly different by primary substance; relatively high rates of risk in the prior 30 days points to continued need for HIV prevention services in outpatient substance abuse treatment. Screened Sample: Characteristics and Eligibility The purpose of this study is to compare baseline demographic and clinical differences across classes of substances among clients recruited into an effectiveness trial of an efficacious, web-based version of the Community Reinforcement Approach (CRA; Onken et al., 1997) plus abstinence-contingent incentives (Budney & Higgins, 1998; Higgins et al., 1994), known as the Therapeutic Education System (TES; [Bickel et al., 2008]). TES was developed to target a range of substance use disorders. Clients were recruited from 10 outpatient drug treatment programs within NIDA’s Clinical Trials Network across 10 states from June 2010-August 2011. Participants completed a brief eligibility screen followed by baseline assessment, and randomization into 12 weeks of treatment as usual (TAU) or TAU + TES. Follow-up assessments were conducted 3- and 6-months post treatment. Final 6-month follow-up data collection will be completed in June 2012.   1,781 participants completed screening; 866 were ineligible, 408 were eligible but not randomized. The randomized sample (n=507) reported varied primary substances of abuse (marijuana 23%; alcohol 21%; opioids 21%; cocaine 20%; stimulants 11%; other 5%). Differences across primary substance were found on age, race/ethnicity, marital status, 12-step attendance, abstinence at baseline, injection drug use, and the social/leisure domain of the Social Adjustment ScaleTM (Weissman & Bothwell, 1976). The study was successful in recruiting a diverse, treatment-seeking sample. Clinical differences across primary substance have implications for treatment engagement and planning, as well as overall trial outcomes. • 1,781 participants screened; 866 ineligible (48.6%), 915 eligible (51.4%) • 44% recruited directly by research staff; 42% via program staff; 9% flyer • 37.2% of screened sample were women; mean age = 35.4 years (SD=11.4) • 507 (55.4%) of 915 eligible participants enrolled; 28.5% of total screened sample • Reasons for ineligibility: 82% no recent illicit substance use; 12% in treatment for > 30 days; 8% prescribed opioid replacement medication • Of eligible/not interested participants: 49.2% time was an issue, 26.9% did not want to participate in research, 7.7% not interested in computer-assisted treatment, and 25.4% other reason • Of eligible/interested participants who scheduled but did not attend baseline: 41.2% failed to show, 25.4% no longer interested, and 23.2% no longer enrolled at treatment program Fig 1. TES Screen Shot Table 1: Randomized Sample Characteristics by Primary of Substance of Abuse (N=483*) METHODS REFERENCES Bickel WK, Marsch LA, Buchhalter A, Badger G. (2008). Computerized behavior therapy for opioid dependent outpatients: A randomized, controlled trial. Experimental and Clinical Psychopharmacology, 16, 132-143. Budney A, Higgins S. (1998). Therapy manuals for drug addiction, a community reinforcement plus vouchers approach: Treating cocaine addiction.Rockville, MD: National Institute on Drug Abuse. Higgins ST, Budney A J, Bickel WK, Foerg FE, Donham R, Badger GJ. (1994). Incentives improve outcome in outpatient behavioral treatment of cocaine dependence. Archives of General Psychiatry, 51, 568-576. Onken LS, Blaine JD, Boren JJ. (Eds.) (1997). Beyond the Therapeutic Alliance: Keeping the Drug-dependent Individual in Treatment. NIDA Research Monograph, 165. Rockville, MD: National Institute on Drug Abuse, NIH Publication: 97-4142. Weissman J, Bothwell S. (1976). Assessment of social adjustment by patient self-report. Archives of General Psychiatry, 33, 1111-1115. Sample: Men and women in participating outpatient substance abuse treatment programs (N=10) who were 18 or older, in the first 30 days of the current treatment episode, reported illicit substance use (with or without alcohol use) in the past 30 days, not currently prescribed an opioid replacement medication, and demonstrated sufficient English literacy for study activities. Procedures: Potential participants were referred to or approached by research staff, provided a brief description of the study and, if interested, completed a 10-minute brief screen (after verbal consent) to assess general eligibility. Eligible and interested clients were scheduled for a baseline assessment, prior to which they completed a full study informed consent. Baseline assessment included measures of daily substance use over the past 90 days (including urine drug and breath alcohol screens), substance use disorder diagnosis, co-occurring psychiatric problems, physical health, social functioning, service utilization, and criminal justice involvement. After baseline, participants were randomized to receive 12 weeks of (1) TAU, or (2) TAU + TES, whereby TES replaced approximately 2 hours of standard treatment per week. Data Analysis: Means and standard deviations or percentages were calculated for each baseline variable. Chi-square tests for categorical variables and F-tests for continuous variables were used to analyze data. Statistics are reported only for tests reaching p  .01. SAS 9.1 was used for all analyses. ACKNOWLEDGMENTS This research was supported by grants from the National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN), U10 DA13035 (EV Nunes & J Rotrosen, Co-PIs) and NIDA K24 DA022412 (EV Nunes). In the preceding 24 months, Dr. Nunes has served on the Lilly advisory board and has received medication from Alkermes/Cephalon, Inc. for research study purposes.We acknowledge and thank the effort of research staff at participating treatment programs, and participants who took part in the study. Inquiries should be directed to the lead author: Aimee Campbell, Ph.D. | Email: anc2002@columbia.edu *‘other’ category of primary substance not included in statistical tests (n=24) Note. X2/F-test values shown only for variables significant at p < .01; superscripts indicate significant differences between primary substance categories