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Completed

NCT Number: NCT00807742

Contingency Management for Smoking in Substance Abusers

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.

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Key information

Conditions

Substance Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University, Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nicotine Replacement Treatment (NRT)

Drug

Nicoderm CQ nicotine skin patch: 21mg patch for 4 weeks, 14mg patch for 2 weeks, 7mg patch for 2 weeks. This is supplemental intervention provided to all.

Other names: Nicoderm CQ skin patch, Nicotine replacement therapy

Brief Advice

Behavioral

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 names: Smoking counseling

Contingency Management

Behavioral

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.

Non-Contingent Reinforcement

Behavioral

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.

Primary outcomes

  1. Number of Participants Smoking Abstinent in Past 7 Days

    Time frame: 1-month follow-up

    7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.

  2. Number of Participants Smoking Abstinent in Past 7 Days

    Time frame: 3-month follow up

    7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.

  3. Number of Participants Smoking Abstinent in Past 7 Days

    Time frame: 6-month follow up

    7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.

  4. Number of Participants Smoking Abstinent in Past 7 Days

    Time frame: 12-month follow up

    7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.

  5. Average Number of Cigarettes Per Day

    Time frame: 1-month follow up

  6. Average Number of Cigarettes Per Day

    Time frame: 3-month follow up

  7. Average Number of Cigarettes Per Day

    Time frame: 6-month follow up

    Timeline Followback interview assessing number of cigarettes on each day of each 3-month reporting period

  8. Average Number of Cigarettes Per Day

    Time frame: 12-month follow up

  9. Number of Participants With Relapse to Any Heavy Drinking

    Time frame: 1-month follow up

    Heavy drinking = 6 or more drinks for men; 5 or more drinks for women

  10. Number of Participants With Relapse to Any Heavy Drinking

    Time frame: 3-month follow up

    Heavy drinking = 6 or more drinks for men; 5 or more drinks for women

  11. Number of Participants With Relapse to Any Heavy Drinking

    Time frame: 6-month follow up

    Heavy drinking = 6 or more drinks for men; 5 or more drinks for women

  12. Number of Participants With Relapse to Any Heavy Drinking

    Time frame: 12-month follow up

    Heavy drinking = 6 or more drinks for men; 5 or more drinks for women

  13. Number of Participants With Relapse to Any Drug Use

    Time frame: 1-month follow up

  14. Number of Participants With Relapse to Any Drug Use

    Time frame: 3-month follow up

  15. Number of Participants With Relapse to Any Drug Use

    Time frame: 6-month follow up

  16. Number of Participants With Relapse to Any Drug Use

    Time frame: 12-month follow up

  17. Percent Smoking Days

    Time frame: 1-month follow up

  18. Percent Smoking Days

    Time frame: 3-month follow up

  19. Percent Smoking Days

    Time frame: 6-month follow up

  20. Percent Smoking Days

    Time frame: 12-month follow up

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Contingent Vouchers for Smoking in Substance Abusers as Adjunct to Nicotine Patch

Acronym: SCMSUD

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2008
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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