NCT00807742

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

January 23, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

5.5 years

First QC Date

December 11, 2008

Results QC Date

April 6, 2018

Last Update Submit

January 16, 2019

Conditions

Substance Abuse

Keywords

Contingency management for smoking for substance abusersContingency reinforcement for smoking abstinenceContingency ManagementNoncontingent Reinforcement

Outcome Measures

Primary Outcomes (20)

  • Number of Participants Smoking Abstinent in Past 7 Days

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

    1-month follow-up

  • Number of Participants Smoking Abstinent in Past 7 Days

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

    3-month follow up

  • Number of Participants Smoking Abstinent in Past 7 Days

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

    6-month follow up

  • Number of Participants Smoking Abstinent in Past 7 Days

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

    12-month follow up

  • Average Number of Cigarettes Per Day

    1-month follow up

  • Average Number of Cigarettes Per Day

    3-month follow up

  • Average Number of Cigarettes Per Day

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

    6-month follow up

  • Average Number of Cigarettes Per Day

    12-month follow up

  • Number of Participants With Relapse to Any Heavy Drinking

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

    1-month follow up

  • Number of Participants With Relapse to Any Heavy Drinking

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

    3-month follow up

  • Number of Participants With Relapse to Any Heavy Drinking

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

    6-month follow up

  • Number of Participants With Relapse to Any Heavy Drinking

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

    12-month follow up

  • Number of Participants With Relapse to Any Drug Use

    1-month follow up

  • Number of Participants With Relapse to Any Drug Use

    3-month follow up

  • Number of Participants With Relapse to Any Drug Use

    6-month follow up

  • Number of Participants With Relapse to Any Drug Use

    12-month follow up

  • Percent Smoking Days

    1-month follow up

  • Percent Smoking Days

    3-month follow up

  • Percent Smoking Days

    6-month follow up

  • Percent Smoking Days

    12-month follow up

Study Arms (2)

Contingency Management (CM)

EXPERIMENTAL

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.

Drug: Nicotine Replacement Treatment (NRT)Behavioral: Brief AdviceBehavioral: Contingency Management

Noncontingent Reinforcement (NR)

ACTIVE COMPARATOR

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)Behavioral: Brief AdviceBehavioral: Non-Contingent Reinforcement

Interventions

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.

Also known as: Nicoderm CQ skin patch, Nicotine replacement therapy
Contingency Management (CM)Noncontingent Reinforcement (NR)
Brief AdviceBEHAVIORAL

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.

Also known as: Smoking counseling
Contingency Management (CM)Noncontingent Reinforcement (NR)
Contingency ManagementBEHAVIORAL

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.

Contingency Management (CM)
Non-Contingent ReinforcementBEHAVIORAL

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.

Noncontingent Reinforcement (NR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University, Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02903, United States

Location

Related Publications (3)

  • Rohsenow DJ, Monti PM, Colby SM, Martin RA. Brief interventions for smoking cessation in alcoholic smokers. Alcohol Clin Exp Res. 2002 Dec;26(12):1950-1. doi: 10.1097/01.ALC.0000041006.59547.9A. No abstract available.

    PMID: 12500132BACKGROUND

  • Rohsenow DJ, Martin RA, Tidey JW, Colby SM, Monti PM. Treating Smokers in Substance Treatment With Contingent Vouchers, Nicotine Replacement and Brief Advice Adapted for Sobriety Settings. J Subst Abuse Treat. 2017 Jan;72:72-79. doi: 10.1016/j.jsat.2016.08.012. Epub 2016 Aug 18.

    PMID: 27658756BACKGROUND

  • Mackillop J, Murphy CM, Martin RA, Stojek M, Tidey JW, Colby SM, Rohsenow DJ. Predictive Validity of a Cigarette Purchase Task in a Randomized Controlled Trial of Contingent Vouchers for Smoking in Individuals With Substance Use Disorders. Nicotine Tob Res. 2016 May;18(5):531-7. doi: 10.1093/ntr/ntv233. Epub 2015 Oct 24.

    PMID: 26498173RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Nicotine Replacement TherapyCrisis Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Damaris Rohsenow, Ph.D.
Organization
Brown University
damaris_rohsenow@brown.edu
401-863-6648

Study Officials

  • Damaris Rohsenow, Ph.D.

    Brown University

    PRINCIPAL INVESTIGATOR

  • Rosemarie Martin, Ph.D.

    Brown University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Research): Behavioral and Social Sciences

Study Record Dates

First Submitted

December 11, 2008

First Posted

December 12, 2008

Study Start

October 1, 2008

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

January 23, 2019

Results First Posted

January 23, 2019

Record last verified: 2019-01

Locations

US(1)