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Smoking Cessation in Substance Abuse Treatment Patients: A Feasibility Study

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Sponsored by
UConn Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine Dependence, Contingency Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Connecticut Health Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2006
Last Updated
November 17, 2011
Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00408265
Brief Title
Smoking Cessation in Substance Abuse Treatment Patients: A Feasibility Study
Official Title
Smoking Cessation in Substance Abuse Treatment Patients: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Nicotine Dependence, Contingency Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Primary Outcome Measure Information:
Title
Percent negative CO readings
Title
Percent negative cotinine readings
Title
Longest period of continuous abstinence
Secondary Outcome Measure Information:
Title
Self-reported frequency and severity of smoking
Title
Objective substance use
Title
Self-reported substance use
Title
Treatment retention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila M Alessi, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

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Smoking Cessation in Substance Abuse Treatment Patients: A Feasibility Study

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