NCT00400751

Brief Summary

Although spousal support predicts the success of a smoker's cessation efforts, "social support" interventions based on teaching partners better support skills have had consistently disappointing results. We examined the potential utility of a family-consultation (FAMCON) intervention based on family-systems theory in a treatment-development project involving 20 couples in which one partner (the primary smoker) continued to smoke despite having or being at significant risk for heart or lung disease. Results were promising. The 50% rate of stable abstinence achieved by primary smokers over at least 6 months exceeds benchmark success rates reported in the literature for other, comparably intensive interventions, suggesting that a couple-focused intervention different in concept and format from social-support interventions tested in the past may hold promise for health-compromised smokers. The FAMCON approach appeared particularly well-suited to female smokers and smokers whose partner also smoked - two sub-groups at high risk for relapse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 1999

Typical duration for phase_1

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

September 1, 1999

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
Last Updated

November 17, 2006

Status Verified

September 1, 1999

First QC Date

November 15, 2006

Last Update Submit

November 16, 2006

Conditions

Keywords

Health-compromised smokers, family cessation intervention

Outcome Measures

Primary Outcomes (3)

  • Point-Prevalence (PP): 30-day abstinence: Smoker and spouse report

  • Percent days abstinence Smoker and spouse report

  • Urges to smoke (self reports)

Secondary Outcomes (3)

  • Health (SF-36)

  • Marital Satisfaction (Hendrick & Hendrick, 1993)

  • State Relationship Questionnaire

Interventions

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient has a diagnosed heart/lung problem or 2+ CAD risk factors
  • patient smoked at least 10 cigarettes per day on average for the previous 6 months
  • couple married or living in a committed relationship for at least 2 years
  • both partners at least 30 years old
  • both partners able to read and speak English
  • both partners willing to participate in FAMCON
  • at least one smoker in the couple hopes to quit within the next two years

You may not qualify if:

  • terminal illness with life expectancy less that 5 years
  • pregnancy
  • history of mania or psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona, Family Research Laboratory, Dept of Psychology

Tucson, Arizona, 85721-0068, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Varda Shoham, Ph.D.

    University of Arizona

    PRINCIPAL INVESTIGATOR
  • Michael J. Rohrbaugh, Ph.D.

    University of Arizona

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 17, 2006

Study Start

September 1, 1999

Study Completion

May 1, 2003

Last Updated

November 17, 2006

Record last verified: 1999-09

Locations