Modafinil vs Placebo for the Treatment of Methamphetamine Dependence (Modafinil)
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|ClinicalTrials.gov Identifier: NCT00469508|
Recruitment Status : Completed
First Posted : May 4, 2007
Results First Posted : March 15, 2013
Last Update Posted : March 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine Dependence||Drug: Modafinil Drug: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Evaluation of Modafinil vs Placebo for the Treatment of Methamphetamine Dependence|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
Active Comparator: Modafinil
Modafinil 400mg oral dose taken daily for 12 weeks
400mg pills taken orally daily for 12 wks.
Other Name: Provigil
Placebo Comparator: Placebo
Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
400mg pills taken orally daily for 12 wks
Other Name: Sugar pill
- Clean Urine Drug Screen [ Time Frame: From randomization to end of week 12 ]Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.
- Retention [ Time Frame: 12 weeks ]The number of persons who completed the medication phase of the trial (12 weeks of medication).
- VAS Score [ Time Frame: baseline and last observation during the 12 week treatment period ]To measure methamphetamine craving, mean change in craving based on visual analog scale (VAS) from 0 (not at all) to 100 (extremely) from baseline to the last week of observation during the 12 week treatment period. The last observation was carried forward if not available during week 12.
- BDI Score [ Time Frame: From baseline to end of treatment period (week 12). ]Self-reported depression: mean change on Beck Depression Index (BDI-II) assessed weekly during the 12 week medication phase. If the week12 measure was not available, the last observation was carried forward. 0 indicates no depression, 63 is the maximum indicating severe depression.
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): NCT00469508
|United States, California|
|UCLA Vine Street Clinic|
|Hollywood, California, United States, 90038|
|Principal Investigator:||Steve Shoptaw, Ph.D.||University of California, Los Angeles|