NCT01723384

Intermittent Naltrexone Among Polysubstance Users

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in reducing relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is inexpensive and has few toxicities but the standard daily regimen for naltrexone is problematic as patients forget to take the medication. Given the challenges in daily dosing, alternate regimen schedules have been proposed to increase efficacy and expand the population that may benefit from this pharmacologic agent. One approach is intermittent targeted administration of naltrexone, whereby individuals take the medication as-needed in anticipation of substance use or during periods of craving. Administration of naltrexone prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone has shown efficacy in reducing heavy alcohol use. However, there have been no studies assessing intermittent targeted dosing of naltrexone among methamphetamine-using and binge-drinking MSM. Polysubstance use patterns are common among MSM, and studies among those who abuse more than one substance are urgently needed. The aims of this study are to determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among non-dependent methamphetamine-using and binge-drinking MSM.

Conditions

• Methamphetamine
• Alcohol

Interventions

Type	Name	Description
DRUG	Intermittent Oral Naltrexone
DRUG	Placebo

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2012-11-07
• Last updated: 2019-04-23
• Results posted: 2019-02-12

Locations

1 site across 1 country: United States