Studying Amphetamine Withdrawal in Humans
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|ClinicalTrials.gov Identifier: NCT01215929|
Recruitment Status : Completed
First Posted : October 7, 2010
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine Dependence||Drug: Dextroamphetamine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Amphetamine Withdrawal Paradigm in Humans|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||May 2014|
|Active Comparator: Dextroamphetamine||
Thirty treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility and be inducted onto d-amphetamine during week 1 of the study. 15 Participants then will be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
|Placebo Comparator: Placebo||
Thirty treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 15 Participants then will be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 week.
- Measure of Methamphetamine Withdrawal [ Time Frame: at the end of week 4 ]Total score on the Methamphetamine Withdrawal Assessment scale (MAWA) based on DSMIV criteria for amphetamine withdrawal. This questionnaire is comprised of 13 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score indicating no methamphetamine withdrawal symptoms is 0 and the maximum score is 4 indicating that a patient has the most severe withdrawal symptom related to that question. The subscales are the 13 questions and the total score is the sum of all the scores for the 13 items on the scale. The range minium and better outcome is a lower score. The range is from 0-52. The worse outcome is reflected in a higher score.
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): NCT01215929
|United States, Arkansas|
|University of Arkansas for Medical SCiences|
|Little Rock, Arkansas, United States, 72205|