Contingency Management for Smoking in Substance Abusers (R21)

November 17, 2011 updated by: UConn Health
Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate abuse or dependence will meet with research staff on two days for quit preparation sessions (2 per day). These sessions include testing a breath sample for evidence of smoking twice each day (separated by at least 5 hours), counseling based on Public Health Service (PHS) guidelines for quitting smoking during the second session each day, and setting a quit date. After these sessions, participants will be randomly assigned to one of two 4-week conditions: (a) standard care or (b) standard care plus prize CM for smoking abstinence with the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL). Nicotine withdrawal and related measures will be assessed throughout the intervention. Follow-up data will be collected through 6-months post-quit date.

Study Overview

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

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

    • 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

All

Description

Inclusion Criteria:

  • current alcohol, cocaine, marijuana, or opiate abuse or dependence
  • smoke ≥ 10 cigarettes per day
  • expired CO > 8 ppm
  • self-reported interest in quitting smoking,
  • ≥ 18 years old
  • willing to provide names, addresses and phone numbers of individuals to assist in locating the participant for follow-up evaluations,
  • English speaking

Exclusion Criteria:

  • currently receiving behavioral therapy or pharmacotherapy for smoking plan to use pharmacotherapy in this quit attempt
  • serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, suicide risk)
  • cognitive impairment
  • 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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Brief counseling based on public health service guidelines.
For 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking. Expired carbon monoxide tests are conducted twice daily and urinary cotinine tests are conducted once each week.
Experimental: B
Brief counseling based on public health service guidelines for quitting smoking plus prize-based contingency management
For 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking. Expired carbon monoxide tests are conducted twice daily and urinary cotinine tests are conducted once each week.
For 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking is delivered. Expired carbon monoxide (CO) tests are conducted twice daily and urinary cotinine tests are conducted once each week. Participants earn the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cigarette smoking abstinence.
Time Frame: Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.
Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Sheila M Alessi, Ph.D., 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

May 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 22, 2008

First Posted (Estimate)

May 23, 2008

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

Other Study ID Numbers

  • 08-081-2
  • R21DA021836-01A2 (U.S. NIH Grant/Contract)

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.

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