CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 7 enrolled
Drug / intervention
Standard clinical care first, followed by standard clinical care and varenicline +1 moredrug
Likely dose
Standard clinical care first, followed by standard clinical care and varenicline 0.5 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/NCT04595318
NCT04595318Phase 4Completed

Feasibility and Preliminary Effectiveness of Varenicline for Co-occurring Cannabis and Tobacco Use

Albert Einstein College of Medicine·interventional·Posted Oct 20, 2020·Updated Sep 24, 2024

In Brief

A Phase 4 clinical trial evaluating Standard clinical care first, followed by standard clinical care and varenicline and Standard clinical care and varenicline first, followed by standard clinical care for Cannabis Dependence and Tobacco Dependence. Completed, enrolled 7 participants.

Detailed Summary

Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 20, 2020
Enrollment StartJan 1, 2015
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.7 years ago

Interventions

Standard clinical care first, followed by standard clinical care and vareniclinedrug

Standard clinical care includes substance use disorder treatment program-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies. Varenicline therapy includes a one month's supply of the medication in standard doses: 0.5 mg for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 21 days.

Standard clinical care and varenicline first, followed by standard clinical caredrug

Standard clinical care includes substance use disorder treatment program-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies. Varenicline therapy includes a one month's supply of the medication in standard doses: 0.5 mg for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 21 days.