Pharmacotherapy & CM for Opioid and Cocaine Dependence
The purpose of this study is to compare the efficacy of the combined treatment modafinil + Contingency Management (CM) to either treatment condition alone or to yoked-controls on cocaine abstinence.
To investigate the role of modafinil-related improvements in memory, impulse control, and attention in mediating cocaine abstinence.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Pharmacotherapy & CM for Opioid and Cocaine Dependence|
- First, we will determine the success of the randomization by comparing the two treatment groups on social-demographic and baseline clinical characteristics using chi-square for categorical variables and ANOVA for continuous variables. [ Time Frame: This is a 16-17 week study per subject over a total time period of 5 years. ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Modafinil
Modafinil from 200mg up to 400mg
Modafinil will be phase in from 200mg to 400mg
Other Name: Modafinil
Placebo Comparator: Sugar Pill
Placebo: sugar pill
Drug: Sugar Pill
placebo, sugar pill will mirror active drug
Other Name: Placebo
We hypothesize that the treatment group receiving the combination of modafinil + Contingency Management will have significantly lower cocaine use than the other treatment conditions. We also hypothesize that improvements in memory, impulse control, and attention will be a significant contributor to the treatment improvements investigated in Specific Aim #1.
Opioid and cocaine dependence are major problems among veteran and non-veterans and no effective pharmacotherapy exists for cocaine dependence. Methadone has not shown robust effectiveness in reducing cocaine abuse. Thus, new treatments are needed for the individuals who have developed cocaine dependence. This study is designed to test a new pharmacotherapy for cocaine dependence and is a placebo-controlled trail.
Currently this study is in data analysis phase with 90 enrolled and 70 completers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838981
|United States, Connecticut|
|Department of Veterans Affairs|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Mehmet Sofuoglu, M.D.,Ph.D.||Yale University|