- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00683033
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
Status
Completed
Conditions
Intervention / Treatment
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
Collaborators
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.
Clinical Trials on Cigarette Smoking
-
Virginia Polytechnic Institute and State UniversityActive, not recruitingCigarette Smoking Behavior | Smoking Behaviors | CigaretteUnited States
-
Maastricht University Medical CenterCompletedCigarette Smoking | Cigarette Smoking Toxicity | Smoking BehaviorNetherlands
-
Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); University of Pennsylvania; Food and Drug Administration...Completed
-
Assistance Publique - Hôpitaux de ParisActive, not recruitingSmoking Cessation | Smoking, Cigarette | Electronic CigaretteFrance
-
Duke UniversityGeorgetown University; University of MichiganWithdrawnSmoking | Cigarette Smoking | E-cigarette Use
-
Pok Oi HospitalNot yet recruitingSmoking ( Cigarette)Hong Kong
-
Ataturk UniversityCompleted
-
Masonic Cancer Center, University of MinnesotaNational Institute on Drug Abuse (NIDA)Active, not recruitingSmoking, CigaretteUnited States
-
RAI Services CompanyIPSOSCompletedSmoking CigaretteUnited Kingdom
-
Yasmeen Alaa Abd El-Hamied AhmeedCompleted
Clinical Trials on Brief smoking cessation counseling
-
University of Wisconsin, MadisonCompletedSmoking | Tobacco Use DisorderUnited States
-
The University of Hong KongCompletedSmoking CessationHong Kong
-
Harvard University Faculty of MedicineNational Institute on Drug Abuse (NIDA)UnknownTobacco AddictionUnited States
-
Kansaa A.IbrahimCompleted
-
Dartmouth-Hitchcock Medical CenterWithdrawn
-
Mayo ClinicUniversity of California, San Francisco; University of Minnesota; Alaska Native...CompletedPregnancy | Nicotine DependenceUnited States
-
University of PennsylvaniaNational Institute on Drug Abuse (NIDA)Completed
-
University of BernUniversity of Zurich; Swiss National Science Foundation; University of Lausanne; University of Geneva, Switzerland and other collaboratorsCompleted
-
University of BernSwiss National Science Foundation; Bernese Lung League; Clinical Trial Unit Grant...CompletedSmoking Cessation | Pulmonary DiseaseSwitzerland
-
University of BernUniversity of Zurich; Swiss National Science Foundation; University of Lausanne; University of Geneva, Switzerland and other collaboratorsCompletedSmoking Cessation | ToxicitySwitzerland