Intermittent Naltrexone Among Polysubstance Users (Project iN)
|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|
|Primary Completion Date :||October 2014|
|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 ]
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|