Cocaine-Related Disorders Clinical Trial
Official title:
N-acetylcysteine as Treatment in Cocaine Addiction
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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