Evaluation of lisdexamfetamine alone and lisdexamfetamine + modafinil for cocaine use disorder

Abstract

s / Drug and Alcohol Dependence 146 (2015) e202–e284 e231 Financial support: NIH NIDA 5R01DA019999 and 5T32DA022981; NIH CTSA program UL1T39 and KL2T63. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.094 Evaluation of lisdexamfetamine alone and lisdexamfetamine+modafinil for cocaine use disorder Alex Brewer1, Daisy G. Thompson-Lake2, James J. Mahoney2, Thomas F. Newton2, Richard De La Garza II 1,2 1 Pharmacology, Baylor College of Medicine, Houston, TX, United States 2 Menninger Department of Psychiatry, Baylor College of Medicine, Houston, TX, United States Aims: Modafinil and sustained release (SR) amphetamine (AMPH) have each shown efficacy for cocaine use disorder, albeit with equivocal results. We hypothesize that a combination medications approachmay bemore efficacious for cocaine use disorder. Thespecificaimof this study is todetermine theeffectsof treatment with lisdexamfetamine alone, and lisdexamfetamine+modafinil, versus placebo, on the subjective and reinforcing effects produced by cocaine in non-treatment-seeking individuals with cocaine use disorder. Methods: In this ongoing study, participants are being recruited from the Houston metropolitan area. All participants meet DSM-IV criteria for cocaine use disorder, and are not seeking treatment. Participants are randomized to placebo, lisdexamfetamine (30mg/day), ormodafinil (200mg/day) + lisdexamfetamine (30mg/day) for 4 days. On day 4, participants complete two selfadministration sessions involving 5 choices for either cocaine (20mg/infusion) or saline. Primary outcome measures include number of choices made for cocaine/saline, and changes in subjective effects and cardiovascular measures. Results: To date, the majority of enrolled participants (N=18) are African American males who smoke cocaine. The majority of individuals also smoke cigarettes, anduse alcohol andmarijuana. In comparison to saline, exposure to cocaine resulted in significantly greater choices for an infusion, increased heart rate and blood pressure, and greater self-reports of positive subjective responses (e.g., “High”, “Any Drug Effect”) (all p’s <0.001). To date, no medication effects have been observed among treatment groups as compared to placebo. Conclusions: Thepreliminaryanalysesdidnot reveal any significant effects produced by the test compounds; however, the group sizes are small (N∼6/group) and data collection is ongoing (final N=20/group). Financial support: Supported by DA023625 (DLG). This work was conducted at, and supported by, the Michael E. DeBakey VA Medical Center, Houston, TX, USA. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.095 Screening and brief treatment for illicit drug use in primary care: Feasibility and acceptability Adam C. Brooks1, Carolyn M. Carpenedo1, Jennifer Lauby2, David Metzger1,3, Elizabeth Byrne2, Kevin Favor4, K.C. Kirby1,3 1 Treatment Research Institute, Philadelphia, PA, United States 2 Public Health Management Corporation, Philadelphia, PA, United States 3 Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States 4 Department of Psychology, Lincoln University, Lincoln University, PA, United States Aims: Brief intervention in primary care settings for illicit drug use has a mixed track record in reducing drug use. We are conducting a randomized clinical trial of a brief intervention (SBIRT) against a 2–6 sessions intervention of brief treatment in three urban federally qualified healthcare centers (FQHCs). Feasibility and acceptability results are reported here. Methods: Primary care patients were screened for risky substance use (alcohol and drug) as they attend regularly scheduled appointments. Consenting patients who screened positive were randomized to receive: (1) SBIRT, conducted in one session and boosted with a 10–15min follow-up within the next month, or (2) SBIRT+, 2–6 sessions incorporating MET, CBT, and boosted with ongoing monthly brief recovery check-ups. Results: 7162 patients were prescreened, and 745 patients demonstrated drug or alcohol risk on the DAST or AUDIT; 414 patients have currently enrolled. Enrolled patients demonstrate a relatively even split between primary alcohol (35%), primarymarijuana (37%) and other illicit drugs (28%). Patients reported frequent drinking days (M=10.07, SD=9.89) and days of drug use (M=14.63, SD=12.08) in the past 30 days. Engagement with both study conditions has been acceptable; SBIRT+ patients attended M=3.56 sessions (SD=1.74). Patient satisfaction and perception of utility regarding clinical procedures has been very high. Approximately 49% of patients to date have been referred to addiction treatment, and 24% have entered treatment. Conclusions: Screening and onsite brief intervention/brief treatment is feasible in urban FQHCS. Heavy substance users enrolled in an ongoing trial in primary care find returning for multiple brief treatment sessions acceptable. Financial support: Commonwealth of Pennsylvania Department of Health SAP 4100055578. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.096 Evaluation of an electronic information system to enhance practice at a medication-assisted opioid treatment program Lawrence S. Brown, Steven Kritz, Melissa Lin, Ben Louie, Roberto Zavala START Treatment and Recovery Centers (formerly ARTC), Brooklyn, NY, United States Aims: START is an outpatient substance abuse program that provides primary care for approximately 3000 adults in NYC. We received funding to evaluate implementation of an electronicmedical record integrating all services. Methods: Quality, Satisfaction, Productivity, and Financial Performance were evaluated utilizing a pre and post-implementation research design. The capabilities of the electronic system were utilized to evaluate Quality, Compliance, and Productivity in all