Effectiveness of N-Acetylcysteine in Treating Cocaine Dependent Individuals - 1
Recent findings have suggested that N-acetylcysteine (NAC) substantially reduces cocaine drug-seeking behavior in formerly cocaine dependent rats. The purpose of this study is to determine the safety, tolerability, and cue reactivity effects of NAC in cocaine dependent individuals and non-dependent healthy controls.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||N-Acetylcysteine as Treatment in Cocaine Addiction|
- Tolerability of N-Acetylcysteine [ Time Frame: Measured throughout both inpatient stays ]
- Reactivity to pictures of cocaine [ Time Frame: Measured after 4th and final dose of med/placebo during each hospital stay ]
- Cocaine withdrawal [ Time Frame: Measured at admission, then discharge, for each hospital stay ]
|Study Start Date:||March 2003|
|Study Completion Date:||September 2005|
Placebo Comparator: 2
Identical appearing placebo pill containing lactose powder, packaged to have similar odor as N-Acetylcysteine in capsule form
Recent findings have suggested that N-acetylcysteine (NAC) substantially reduces cocaine-primed drug-seeking behavior in formerly cocaine dependent rats. The purpose of this study is to determine the safety, tolerability, and cue reactivity effects of NAC in cocaine dependent individuals and non-dependent healthy controls.
Participants in this study will include 20 non-treatment seeking cocaine dependent individuals and 12 healthy, non-dependent controls. Participants will be recruited via word-of-mouth and advertisements. Cocaine dependent participants will undergo two 3-day hospital stays. Healthy controls will be followed throughout the study on an outpatient basis. All participants will be randomly assigned to receive either 600 mg of NAC or placebo. Medication or placebo will be administered twice each day. Participants will be evaluated for side effects throughout the study. After administration of the final dose of medication or placebo, participants will undergo cue reactivity testing. This will include a standardized protocol of slides demonstrating cocaine acquisition, use of cocaine, and cocaine-related paraphernalia. Before, during, and after cue reactivity procedures, standardized behavioral and cognitive scales will be used to assess cocaine craving, cocaine seeking, and subjective effects of the cocaine "high." The following week participants will be crossed over so that they will receive the other treatment. All study procedures will be performed a second time. Participants will be contacted during Week 3 in order to determine if any residual side effects or adverse events occurred from the medication and treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136825
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Steven D LaRowe, Ph.D.||Medical University of South Carolina|