Trial Outcomes & Findings for Efficacy of Varenicline in Methadone-Stabilized Cocaine Users (NCT NCT00567320)

Results Overview

Urine samples were obtained thrice-weekly and analyzed for the presence of cocaine metabolites. Levels that exceeded 300 ng / ml on each individual urine test were considered positive. The primary outcome measure was the proportions of positive cocaine urine results per week that was calculated by using the total number of completed tests as the denominator and the total number of positive tests for that week as the numerator. This data was subjected to Hierarchical Linear Modeling (HLM) analysis using a total of 13 longitudinal results that included a baseline result (Week 0).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Weekly Measures over 12 weeks

Results posted on

2020-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Varenicline Varenicline 2 mg per day.	Placebo This is the Placebo condition
Overall Study STARTED	13	18
Overall Study COMPLETED	13	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Varenicline in Methadone-Stabilized Cocaine Users

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varenicline n=13 Participants Varenicline 2 mg per day.	Placebo n=18 Participants This is the Placebo condition	Total n=31 Participants Total of all reporting groups
Age, Continuous	36.5 years STANDARD_DEVIATION 12 • n=5 Participants	34.4 years STANDARD_DEVIATION 12 • n=7 Participants	35.45 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	18 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Weekly Measures over 12 weeks

Population: Intention to treat analysis of all subjects receiving medication

Urine samples were obtained thrice-weekly and analyzed for the presence of cocaine metabolites. Levels that exceeded 300 ng / ml on each individual urine test were considered positive. The primary outcome measure was the proportions of positive cocaine urine results per week that was calculated by using the total number of completed tests as the denominator and the total number of positive tests for that week as the numerator. This data was subjected to Hierarchical Linear Modeling (HLM) analysis using a total of 13 longitudinal results that included a baseline result (Week 0).

Outcome measures

Outcome measures
Measure	Varenicline n=13 Participants Varenicline 2 mg per day.	Placebo n=16 Participants This is the Placebo condition
Proportion of Cocaine Positive Urine Tests Per Week	.57 Proportion of cocaine positive Standard Deviation .05	.58 Proportion of cocaine positive Standard Deviation .05

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mehmet Sofuoglu, M.D., Ph.D.

Yale University

Phone: 203-937-4809

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place