Smoking Cessation in Substance Abuse Treatment Patients: A Feasibility Study

November 17, 2011 updated by: UConn Health
The purpose of this study is to compare the effects of self-help materials for smoking cessation and self-help materials for smoking cessation plus prize-based contingency management (CM), in which prize incentives are available for breath and saliva samples that indicate smoking abstinence, in substance abuse treatment patients who want to quit smoking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The specific aims of this study are: (1) to examine the efficacy of self-help materials compared to self-help materials plus prize contingency management (CM) for smoking abstinence in substance abuse treatment patients and (2) examine the effects of smoking abstinence on substance use and substance treatment retention. To address these specific aims, cigarette smokers entering treatment for alcohol, cocaine or heroin abuse or dependence, who report daily smoking (at least one cigarette per day) for the past year, and who meet other inclusion and exclusion criteria, are randomly assigned to receive self-help materials or self-help materials plus CM. Individuals in the CM group have the opportunity to win prizes, worth on average $1, $20, or $100, when they meet smoking abstinence criteria (CO < 8ppm and salivary cotinine < 10ng/mL). Participants meet with research staff 4 times/week during Weeks 1-4, 2 times/week during Weeks 5-8 and 1 time/week during Weeks 9-12. Follow-up interviews are scheduled 1, 3 and 6 months following the smoking quit date.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • meets diagnostic criteria for alcohol, cocaine or heroin abuse or dependence
  • self-report daily smoking for at least the past year
  • CO > 8ppm
  • interested in quitting smoking while in treatment,
  • minimum age 18 years old
  • willing to provide names, addresses and phone numbers of individuals to assist in locating the patient for follow-up evaluations
  • English speaking

Exclusion Criteria:

  • current use of NRT
  • current use of bupropion
  • serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, suicide risk)
  • dementia (Mini-mental status score of <23)
  • currently participating in another CM study at the clinic
  • in recovery for pathological gambling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent negative CO readings
Percent negative cotinine readings
Longest period of continuous abstinence

Secondary Outcome Measures

Outcome Measure
Treatment retention
Self-reported frequency and severity of smoking
Objective substance use
Self-reported substance use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Sheila M Alessi, PhD, UConn Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

December 4, 2006

First Submitted That Met QC Criteria

December 4, 2006

First Posted (Estimate)

December 6, 2006

Study Record Updates

Last Update Posted (Estimate)

November 21, 2011

Last Update Submitted That Met QC Criteria

November 17, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAA-ALE-03510
  • NIH Grant P50-AA03510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe