NCT00408265

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2004

Typical duration for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

November 21, 2011

Status Verified

November 1, 2011

Enrollment Period

3.2 years

First QC Date

December 4, 2006

Last Update Submit

November 17, 2011

Conditions

Keywords

Nicotine DependenceContingency Management

Outcome Measures

Primary Outcomes (3)

  • Percent negative CO readings

  • Percent negative cotinine readings

  • Longest period of continuous abstinence

Secondary Outcomes (4)

  • Self-reported frequency and severity of smoking

  • Objective substance use

  • Self-reported substance use

  • Treatment retention

Interventions

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Sheila M Alessi, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 6, 2006

Study Start

January 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

November 21, 2011

Record last verified: 2011-11

Locations