Smoking Cessation in Substance Abuse Treatment Patients: A Feasibility Study

Nicotine Dependence Clinical Trial

Official title:

Smoking Cessation in Substance Abuse Treatment Patients: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408265
• Other study ID #: NIAAA-ALE-03510
• Secondary ID: NIH Grant P50-AA
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2006
• Last updated: November 17, 2011
• Start date: January 2004
• Est. completion date: March 2007

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Contingency Management

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 Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent negative CO readings
Primary	Percent negative cotinine readings
Primary	Longest period of continuous abstinence
Secondary	Self-reported frequency and severity of smoking
Secondary	Objective substance use
Secondary	Self-reported substance use
Secondary	Treatment retention