Clinical Trials Directory

Trials / Completed

CompletedNCT01063205

NAC as a Potential Treatment for Methamphetamine Dependence

N-AcetylCysteine as a Potential Treatment of Methamphetamine Dependence

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Baylor College of Medicine · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine the effects of treatment with NAC, compared to treatment with placebo, on cue- and methamphetamine (MA)-induced craving and MA subjective effects in non-treatment-seeking MA-dependent human volunteers. We also aim to determine the effects of treatment with NAC, compared to treatment with placebo, on the reinforcing effects of MA by measuring MA self-administration in non-treatment-seeking MA-dependent human volunteers.

Detailed description

N-acetyl-l-cysteine (NAC) treatment is associated with reduced susceptibility to reinstatement of cocaine seeking behavior in rats (Baker et al 2002) and with reduced cue-induced craving in cocaine-dependent human volunteers (LaRowe et al 2006). We propose these aims to evaluate the potential of NAC as a treatment for methamphetamine (MA) dependence: Specific Aim 1: To determine the effects of treatment with NAC(placebo, 1800 and 3600mg daily), compared to treatment with placebo, on cue- and MA-induced craving and MA subjective effects in non-treatment-seeking MA-dependent human volunteers. We hypothesize that treatment with NAC will reduce craving for MA reported following exposure to MA cues and will reduce craving and MA subjective effects reported following non-contingent administration of MA (0mg,9mg, and 30 mg, IV). Specific Aim 2: To determine the effects of treatment with NAC (placebo, 1800 and 3600mg daily), compared to treatment with placebo, on the reinforcing effects of MA by measuring MA self-administration in non-treatment-seeking MA-dependent human volunteers. We hypothesize that treatment with NAC will reduce the number of choices made for MA during choice sessions.

Conditions

Interventions

TypeNameDescription
DRUGPlaceboPlacebo administration will be started on day 2 and stopped on day 5. Methylsulonylmethane (MSM) will serve as a placebo for MA.
DRUGN-acetylcysteineStudy medication (NAC 1800 mg) will be started on day 2 and stopped on day 5.
DRUGN-acetylcysteineStudy medication (NAC 3600 mg) will be started on day 2 and stopped on day 5.

Timeline

Start date
2010-03-01
Primary completion
2011-07-01
Completion
2011-07-01
First posted
2010-02-05
Last updated
2012-07-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01063205. Inclusion in this directory is not an endorsement.