A Sequenced Behavioral and Medication Intervention for Cocaine Dependence
Summary
This study will investigate a treatment strategy in which a computer-assisted behavioral intervention will be used to help individuals stop their use of cocaine. A medication will be combined with the behavioral treatment among those individuals who do not respond to the behavioral intervention alone. The primary hypothesis of the study is that among cocaine dependent individuals who fail to respond to an initial trial of behavioral therapy, a greater proportion of individuals will benefit from the combined treatment (behavior therapy plus medication) compared to individuals in the comparison group.
Timeline
- Start
- 2014-01
- Primary completion
- 2021-01
- Completion
- 2021-01
Outcome
Missed primary endpoint
paper The proportion of participants demonstrating 3 consecutive weeks of abstinence at study end did not differ between the medication groups: MAS-ER = 15.6% (7/45) and placebo = 12.2% (5/41). PMID 37732961 ↗
paper augmenting a behavioral intervention with MAS-ER did not significantly increase the abstinence rate PMID 37732961 ↗
Publications
- Background Bickel WK, Marsch LA, Buchhalter AR, Badger GJ. Computerized behavior therapy for opioid-dependent outpatients: a randomized controlled trial. Exp Clin Psychopharmacol. 2008 Apr;16(2):132-43. doi: 10.1037/1064-1297.16.2.132.
- Carpenter KM, Choi CJ, Basaraba C, Pavlicova M, Brooks DJ, Brezing CA, Bisaga A, Nunes EV, Mariani JJ, Levin FR. Mixed amphetamine salts-extended release (MAS-ER) as a behavioral treatment augmentation strategy for cocaine use disorder: A randomized clinical trial. Exp Clin Psychopharmacol. 2024 Feb;32(1):112-127. doi: 10.1037/pha0000676. Epub 2023 Sep 21.
- Blevins D, Carpenter KM, Martinez D, Mariani JJ, Levin FR. An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders. Contemp Clin Trials. 2020 Nov;98:106187. doi: 10.1016/j.cct.2020.106187. Epub 2020 Oct 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mixed amphetamine salts-extended release | Unknown | 80 mg | — |