CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Varenicline +1 moredrug
Likely dose
Varenicline 2 mgfrom 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/NCT00567320
NCT00567320N/ACompleted

Efficacy of Varenicline in Methadone-Stabilized Cocaine Users

Yale University·interventional·Posted Dec 4, 2007·Updated Apr 2, 2020

In Brief

A clinical study evaluating Varenicline and Sugar pill or Placebo for Cocaine Dependence and Nicotine Dependence. Completed, enrolled 31 participants across 1 site.

Detailed Summary

Cocaine addiction continues to be an important public health problem in the US with a significant cost to the individual and society. Among substance abusers, cocaine use has been recognized as a significant problem especially in methadone-maintenance patients. In several studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer 1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is of great importance. Unfortunately, such effective pharmacotherapies do not exist. 1. To determine the safety and tolerability of varenicline in cocaine-using methadone-stabilized subjects. 2. To determine if varenicline is efficacious in reducing cocaine-use in methadone-stabilized subjects.

Study Details

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

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 4, 2007
Enrollment StartMar 1, 2007
Primary CompletionJun 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.6 years ago

Interventions

Vareniclinedrug

Varenicline up to 2 mg a day

Sugar pill or Placebodrug

Placebo