NCT00683033

Brief Summary

Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate abuse or dependence will meet with research staff on two days for quit preparation sessions (2 per day). These sessions include testing a breath sample for evidence of smoking twice each day (separated by at least 5 hours), counseling based on Public Health Service (PHS) guidelines for quitting smoking during the second session each day, and setting a quit date. After these sessions, participants will be randomly assigned to one of two 4-week conditions: (a) standard care or (b) standard care plus prize CM for smoking abstinence with the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL). Nicotine withdrawal and related measures will be assessed throughout the intervention. Follow-up data will be collected through 6-months post-quit date.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2008

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

May 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 21, 2011

Status Verified

November 1, 2011

Enrollment Period

2.4 years

First QC Date

May 14, 2008

Last Update Submit

November 17, 2011

Conditions

Keywords

Contingency ManagementCigarette Smoking CessationSubstance Abusers

Outcome Measures

Primary Outcomes (1)

  • Cigarette smoking abstinence.

    Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.

Study Arms (2)

A

ACTIVE COMPARATOR

Brief counseling based on public health service guidelines.

Behavioral: Brief smoking cessation counseling

B

EXPERIMENTAL

Brief counseling based on public health service guidelines for quitting smoking plus prize-based contingency management

Behavioral: Contingency ManagementBehavioral: Brief smoking cessation counseling

Interventions

For 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking is delivered. Expired carbon monoxide (CO) tests are conducted twice daily and urinary cotinine tests are conducted once each week. Participants earn the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL).

B

For 4 weeks starting on the quit date, daily brief (about 5 minutes) counseling based on public health service guidelines for quitting smoking. Expired carbon monoxide tests are conducted twice daily and urinary cotinine tests are conducted once each week.

AB

Eligibility Criteria

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

You may qualify if:

  • current alcohol, cocaine, marijuana, or opiate abuse or dependence
  • smoke ≥ 10 cigarettes per day
  • expired CO \> 8 ppm
  • self-reported interest in quitting smoking,
  • ≥ 18 years old
  • willing to provide names, addresses and phone numbers of individuals to assist in locating the participant for follow-up evaluations,
  • English speaking

You may not qualify if:

  • currently receiving behavioral therapy or pharmacotherapy for smoking plan to use pharmacotherapy in this quit attempt
  • serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, suicide risk)
  • cognitive impairment
  • 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

Cigarette SmokingTobacco Use Cessation

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseHealth Behavior

Study Officials

  • Sheila M Alessi, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 23, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 21, 2011

Record last verified: 2011-11

Locations