Intermittent Naltrexone Among Polysubstance Users (Project iN)
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|ClinicalTrials.gov Identifier: NCT01723384|
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : December 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine Alcohol||Drug: Intermittent Oral Naltrexone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: Naltrexone
Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks.
|Drug: Intermittent Oral Naltrexone|
Placebo Comparator: Placebo
Intermittent oral placebo to be taken on an as-needed basis for 8 weeks
- Feasibility [ Time Frame: proportions eligible and enrolled assessed on ongoing basis throughout the study, proportion of visits completed assessed bi-weekly for each participant; overall retention assessed over 2 month follow-up for each participant ]Proportion of persons screened who are eligible and enrolled; proportion of scheduled study visits completed; final retention by study arm.
- Tolerability [ Time Frame: at each bi-weekly visit throughout the 2 month follow-up for each participant ]Comparison of adverse events in the naltrexone and placebo arms.
- Acceptability [ Time Frame: adherence assessed daily through electronic monitoring, pill count and self-report assessed at bi-weekly visits over the course of 2 month follow-up ]Adherence to naltrexone and placebo, as determined via electronic monitoring device (WisePill) data, pill count, and self-report.
- Methamphetamine use and drinking outcomes [ Time Frame: assess at baseline, month 1 and month 2 visits ]
- Sexual Behaviors [ Time Frame: assessed at baseline, month 1 and 2 visits ]
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): NCT01723384
|United States, California|
|San Francisco Department of Public Health, Substance Use Research Unit|
|San Francisco, California, United States, 94102|
|Principal Investigator:||Glenn-Milo Santos, PhD||University of California, San Francisco|
|Study Director:||Jason Euren, MA||San Francisco Department of Public Health|