Contingency Management for Smoking in Substance Abusers

Cigarette Smoking Clinical Trial

— R21  

Official title:

Contingency Management for Smoking in Substance Abusers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683033
• Other study ID #: 08-081-2
• Secondary ID: R21DA021836-01A2
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2008
• Last updated: November 17, 2011
• Start date: May 2008
• Est. completion date: October 2010

Study information

• Verified date: November 2011
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• 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 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).
• Brief smoking cessation counseling
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.

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut Health Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarette smoking abstinence.		Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.	No