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Contingency Management for Smoking in Substance Abusers (SCMSUD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Brown University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Brown University
ClinicalTrials.gov Identifier:
NCT00807742
First received: December 11, 2008
Last updated: June 23, 2011
Last verified: February 2009
  Purpose

The aim of this study is to determine whether contingent reinforcement for smoking abstinence, compared to noncontingent reinforcement, increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment.


Condition Intervention
Substance Abuse
Drug: Nicotine Replacement Treatment (NRT)
Behavioral: Brief Advice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Contingent Vouchers for Smoking in Substance Abusers as Adjunct to Nicotine Patch

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Point-prevalence abstinence [ Time Frame: 1-, 3-, 6- and 12-month follow-up periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Substance use, within-treatment abstinence, self-efficacy about smoking cessation, motivation level, and tolerance for smoking discomfort. [ Time Frame: 1-, 3-, 6- and 12-month follow-ups ] [ Designated as safety issue: No ]

Estimated Enrollment: 274
Study Start Date: October 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contingency Management (CM)
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence. A system of laptop recording, vouchers and certificates, will be used.
Drug: Nicotine Replacement Treatment (NRT)
Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Other Names:
  • Nicoderm CQ skin patch
  • Nicotine replacement therapy
Behavioral: Brief Advice
Brief Advice (BA): Patients will receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
Other Name: Smoking counseling
Noncontingent Reinforcement (NR)
Controls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained.
Drug: Nicotine Replacement Treatment (NRT)
Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, then 14mg patch for 2 weeks and 7mg patch for 2 weeks. This is supplemental intervention provided to all.
Other Names:
  • Nicoderm CQ skin patch
  • Nicotine replacement therapy
Behavioral: Brief Advice
Brief Advice (BA): Patients will receive four sessions of a manualized brief intervention based on NCI guidelines (Manley et al., 1991; Hollis et al., 1993) as modified for sobriety settings. This simple counseling has five components: (1) Assess smoking and initial interest in cessation; (2) Advise the patient to quit smoking; (3) Assist the patient in quitting; (4) Assess interest in quitting; and (5) Arrange booster sessions. This supplemental information is provided to all.
Other Name: Smoking counseling

Detailed Description:

Substance abusers have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking.

The aim of this study is to determine whether contingent reinforcement for smoking abstinence (CM), compared to noncontingent reinforcement (NR), increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment. The proposed study will be a 2-group design in which up to 274 substance abusers who smoke 10 or more cigarettes per day receive brief advice (4 sessions) and nicotine replacement (NRT) (8 weeks), and are randomized to 19 days of CM for smoking vs. a matched NR condition. The brief advice is adapted slightly for sobriety settings. Point-prevalence abstinence will be assessed at 1, 3, 6 and 12 months after starting treatment. Secondary aims evaluate effects of CM on substance use outcomes and potential mediators of effects on outcome, including within-treatment abstinence, motivation level and tolerance for smoking discomfort.

The significance is to add knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this population.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of substance abuse or dependence by DSM-IV criteria
  • in residential treatment at one particular agency
  • currently smoking at least 10 cigarettes per day for the past 6 months

Exclusion Criteria:

  • hallucinating or delusional or marked organic impairment (to the point of impairing ability to understand informed consent) according to medical records
  • current use of nicotine replacement therapy, Zyban, or any other smoking cessation treatment
  • medical exclusions for NRT: pregnant or nursing; treatment in the last 3 months for unstable angina, severe congestive heart failure, uncontrolled hypertension; lung cancer; supplemental oxygen; history of adverse reactions to NRT; allergies to adhesive; or any severe skin disease that requires treatment (e.g., psoriasis or eczema).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807742

Contacts
Contact: Rebecca Uth, M.A. (401) 863-6608 rebecca_uth@brown.edu

Locations
United States, Rhode Island
Brown University, Center for Alcohol and Addiction Studies Recruiting
Providence, Rhode Island, United States, 02903
Contact: Damaris Rohsenow, Ph.D.         
Principal Investigator: Damaris J. Rohsenow, Ph.D.         
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Damaris Rohsenow, Ph.D. Brown University
Study Director: Rosemarie Martin, Ph.D. Brown University
  More Information

Publications:
Responsible Party: Damaris Rohsenow, Ph.D./Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00807742     History of Changes
Other Study ID Numbers: 1R01DA023995-01, NIH award # 1R01DA023995-01
Study First Received: December 11, 2008
Last Updated: June 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
Contingency management for smoking for substance abusers
Contingency reinforcement for smoking abstinence
Contingency Management
Noncontingent Reinforcement

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014