NAC as a Potential Treatment for Methamphetamine Dependence
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|ClinicalTrials.gov Identifier: NCT01063205|
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : July 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine Abuse Methamphetamine Dependence Substance Abuse||Drug: Placebo Drug: N-acetylcysteine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||N-AcetylCysteine as a Potential Treatment of Methamphetamine Dependence|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
|Placebo Comparator: Placebo||
Placebo administration will be started on day 2 and stopped on day 5. Methylsulonylmethane (MSM) will serve as a placebo for MA.
Other Name: Methylsulonylmethane (MSM)
|Active Comparator: N-Acetylcysteine (NAC) 1800 mg||
Study medication (NAC 1800 mg) will be started on day 2 and stopped on day 5.
Other Name: NAC
|Active Comparator: N-Acetylcysteine (NAC) 3600 mg||
Study medication (NAC 3600 mg) will be started on day 2 and stopped on day 5.
Other Name: NAC
- The effects of treatment with NAC (placebo, 1800 and 3600 mg daily), compared to treatment with placebo, on cue- and MA-induced craving and subjective effects in MA-dependent human volunteers.On days 3-5, participants will take part in active cues and neutral cues. On days 4 and 5, they will make choices to receive MA/placebo in a self-administration paradigm. Participants will also rate craving, desire, and would take MA if available on a 0-100 mm visual analogue scale.
- The effects of treatment with NAC (placebo, 1800 and 3600 mg daily), compared to treatment with placebo, on the reinforcing effects of MA by measuring MA self-administration in MA-dependent human volunteers.On days 4 and 5, participants will make choices to receive MA/placebo in a self-administration paradigm. Any alterations in the reinforcing effects of MA associated with NAC treatment will be evident as changes in the number of choices made for MA.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063205
|United States, Texas|
|Michael E. DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas Newton, MD||Baylor College of Medicine|