Tobacco Intervention in Buprenorphine Treatment

NCT01350011 | Completed Phase 3 DMC

• 2 other identifiers: P030871P50DA009253
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nicotine Replacement Therapy; Buprenorphine; Varenicline; Smoking Cessation; Addiction; The Innovative System (IS) Treatment; The Standard Treatment Control (STC)

Outcome Measures

Primary Outcomes (1)

• Smoking Status

  Smoking status is defined as "no cigarettes for the past 7 days."

  3, 6, 12, and 18 Months

Study Arms (2)

Innovative System (IS)

ACTIVE COMPARATOR

The innovative intervention uses the treatment system to support motivational counseling treatment entrance and treatment utilization. It has two components, a Motivational Intervention component via Expert System Counseling, and a Treatment Component that incorporates both pharmacological and behavioral long-term components. An innovative aspect of the IS is the use of the pharmacist as an intervention agent, who queries participants on their readiness to quit smoking, encourages involvement in the motivational intervention and in treatment, and who, along with the counselors, is available to answer medication questions.

Behavioral: Innovative System

Standard Treatment Control

ACTIVE COMPARATOR

After a baseline interview, patients in this condition will be given a packet of brochures on quitting, including descriptions of self-quitting and help-lines. Participants in this condition will continue to have access to their primary care providers, and through that system have access to pharmacotherapy for smoking cessation, if they wish to receive it. They will receive written instructions on how to approach their primary care provider about smoking cessation medication, and a written description of the medications used in smoking cessation and a list of those that are available to them through the public health system. At each assessment, patients will be queried about their use of these resources.

Behavioral: Standard Treatment Control (STC)

Interventions

Innovative System BEHAVIORAL

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.

Innovative System (IS)

Standard Treatment Control (STC) BEHAVIORAL

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

Standard Treatment Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants must smoke five or more cigarettes a day and be registered patients at Integrated Buprenorphine Intervention Services (IBIS) of the San Francisco Department of Public Health.

You may not qualify if:

• Participants with contraindications to NRT will be excluded. Thus, participants who have had a myocardial infarction within the last three months, or who have uncontrolled high blood pressure will be excluded. We will exclude pregnant or nursing women.
• Participants with contraindications to varenicline treatment will be included in the study but will not be eligible for varenicline treatment.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Behavioral Health Access Center

San Francisco, California, 94103, United States

Location

Related Publications (1)

• Hall SM, Humfleet GL, Gasper JJ, Delucchi KL, Hersh DF, Guydish JR. Cigarette Smoking Cessation Intervention for Buprenorphine Treatment Patients. Nicotine Tob Res. 2018 Apr 2;20(5):628-635. doi: 10.1093/ntr/ntx113.

  PMID: 28549161 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Behavior, Addictive

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Compulsive Behavior; Impulsive Behavior

Study Officials

• Sharon Hall, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 9, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

US (1)