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Smoking Cessation in Substance Abuse Treatment Patients: A Feasibility Study

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ClinicalTrials.gov Identifier: NCT00408265
Recruitment Status : Completed
First Posted : December 6, 2006
Last Update Posted : November 21, 2011
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
UConn Health

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Behavioral: Contingency Management Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking Cessation in Substance Abuse Treatment Patients: A Feasibility Study
Study Start Date : January 2004
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Percent negative CO readings
  2. Percent negative cotinine readings
  3. Longest period of continuous abstinence

Secondary Outcome Measures :
  1. Self-reported frequency and severity of smoking
  2. Objective substance use
  3. Self-reported substance use
  4. Treatment retention


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408265


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Sheila M Alessi, PhD UConn Health

Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT00408265     History of Changes
Other Study ID Numbers: NIAAA-ALE-03510
NIH Grant P50-AA03510
First Posted: December 6, 2006    Key Record Dates
Last Update Posted: November 21, 2011
Last Verified: November 2011

Keywords provided by UConn Health:
Nicotine Dependence
Contingency Management

Additional relevant MeSH terms:
Substance-Related Disorders
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders