CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Long-acting injectable naltrexonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02088177
NCT02088177Phase 2Completed

Open-Label Pilot Study of Long-Acting Injectable Naltrexone Treatment for Cannabis Dependence

New York State Psychiatric Institute·interventional·Posted Mar 14, 2014·Updated Apr 24, 2019

In Brief

A Phase 2 clinical trial evaluating Long-acting injectable naltrexone for Cannabis Dependence. Completed, enrolled 12 participants across 2 sites.

Detailed Summary

This is an 8 week, outpatient research study testing the use of long-acting naltrexone (Vivitrol) as a treatment for marijuana dependence. Vivitrol is a medication that is effective in treating dependence on opiates and opioids, and in treating dependence on alcohol. It is FDA approved for these disorders. It is a long-acting medication that contains enough medicine in each injection to last for one month. One way it works is by blocking the effects of opiates, including opiates released by the body in response to drugs and alcohol. In this study, we are interested in testing the effects of Vivitrol in people with marijuana dependence. Individuals participating in this study will receive two Vivitrol injections, each given four weeks apart, (week 1 and week 5). The injection is given in the muscle of the buttock on one side. Participants will attend clinic visits two times a week during this 8-week study for medical management for drug use and for monitoring of physical and psychological health.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 14, 2014
Enrollment StartOct 1, 2014
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.3 years ago

Interventions

Long-acting injectable naltrexonedrug

Vivitrol is a long-acting opioid antagonist which blocks opioid agonists from binding at opioid receptors. It be administered as described above.