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| Sponsors and Collaborators: |
New York University School of Medicine Forest Laboratories |
|---|---|
| Information provided by: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00571922 |
Purpose
This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary ouitcome is methamphetamine nabsitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urines positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.
| Condition | Intervention | Phase |
|---|---|---|
|
Methamphetamine Dependence, Treatment Seeking |
Drug: Acamprosate Drug: placebo |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Placebo-Controlled, Double Blind, Randomized Trial of Acamprosate for the Treatment of Methamphetamine Dependence |
| Estimated Enrollment: | 72 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | September 2008 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Acamprosate
|
Drug: Acamprosate
2 gr/day (333 mg, TID)
|
|
2: Placebo Comparator
placebo medication
|
Drug: placebo
matching placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dan Rutimann, BA | 212-686-7500 ext 3013 | daniel.rutimann@va.gov |
| United States, New York | |
| VA New York Harbor Healthcare System, MHAD clinic | Recruiting |
| New York, New York, United States, 10010 | |
| Contact: Dan Rutimann, BA 212-686-7500 ext 3013 daniel.rutimann@va.gov | |
| Principal Investigator: Malcolm S. Reid, Ph.D. | |
| Principal Investigator: | Malcolm Reid, PhD | New York University School of Medicine |
More Information
| Responsible Party: | New York University School of Medicine, Department of Psychiatry ( Malcolm S. Reid, Assistant Professor ) |
| Study ID Numbers: | AcamprosateMethamphetamine, CMP-MD-17 |
| Study First Received: | December 10, 2007 |
| Last Updated: | December 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00571922 |
| Health Authority: | United States: Institutional Review Board |
|
methamphetamine, crystal, treatment |
|
Methamphetamine Behavior, Addictive Dopamine |
Amphetamine Ethanol Acamprosate |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sympathomimetics Adrenergic Uptake Inhibitors Physiological Effects of Drugs |
Central Nervous System Stimulants Pharmacologic Actions Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents Alcohol Deterrents |
