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Tobacco Intervention in Buprenorphine Treatment

NCT01350011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2018-11-13

No results posted yet for this study

Summary

Drug addiction treatment patients, including those in treatment for opioid dependence, have a high rate of tobacco dependence, especially cigarette smoking. The proposed study evaluates an Innovative System (IS) for the treatment of tobacco dependence in one group of opioid treatment patients, those in buprenorphine maintenance. The specific aims of the study are to test the efficacy and the cost effectiveness of the IS.

A secondary aim is obtain preliminary data about differences in use of non-nicotinic drugs between participants who achieve abstinence from cigarettes during the study, and those who do not.

Conditions

  • Tobacco Dependence

Interventions

BEHAVIORAL

Innovative System

In IS, they will receive motivational counseling at months 3,6,12, and 18. If they decide to quit smoking they will be offered up to 10 sessions of behavioral counseling and access to NRT (nicotine patch and gum) If they relapse on NRT, they will be offered varenicline, if it is not contraindicated.

BEHAVIORAL

Standard Treatment Control (STC)

Participants will receive self help information and referrals for counseling and for pharmacological treatment.

Sponsors & Collaborators

Principal Investigators

  • Sharon Hall, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-01
Primary Completion
2016-04-01
Completion
2016-12-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01350011 on ClinicalTrials.gov