Recycling Attempters and Relapsers in Smoking Cessation

February 26, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To study the process of recycling failed smoking cessation attempts and relapses.

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

Depending on the type of treatment, between 25 percent and 80 percent of smokers fail to quit with a program, and of those who initially quit, as many as 80 percent may relapse within a year. Thus, we need to understand more about the consequences of these 'failures' on subsequent cessation attempts and success and to develop more effective treatment programs to recycle these smokers into sustained abstinence.

DESIGN NARRATIVE:

The study focused on two subsets of smokers frequently ignored by researchers and intervention programs: subjects who failed to quit with a cessation program and subjects who relapsed after achieving abstinence. The primary aim was to develop and evaluate the efficacy of an intervention tailored to stage of change (still smoking, abstinent, relapsed) that used extended contact, motivation, and efficacy building strategies to: 1) increase the percentage of subjects who achieved subsequent abstinence after failing to quit with a core group treatment; 2) decrease relapse rates; and 3) increase the rate of sustained recycling (i.e., maintained abstinence) following a relapse. The investigators also tested the extent to which the effects on abstinence were explained by the mediating variables of motivation and self- efficacy. Secondary aims included: 1) examining the role of several psychosocial variables in the maintenance, relapse, and cessation processes; 2) describing and examining longitudinal changes following smoking cessation; and 3) examining the long-term (beyond two years) effects of the study's intervention.

The design of the study comprised two conditions: 1) Control Condition (N = 452) and 2) Enhanced Treatment Condition (N = 452). the two treatment conditions had a common core seven-week cessation and relapse prevention group program. Following the group program, the two conditions differed in both format and content of treatment. Subjects in the Control Condition received seven counselor-initiated phone calls over a three month period. The content of the phone calls represented the most effective components of the study and varied depending on whether the subjects were smoking or abstinent. Treatment in the Enhanced Condition was tailored to three groups of subjects: smokers, abstainers, and relapsers. Subjects who were smoking at the end of the core program received three more weekly group meetings followed by three phone calls, and then six monthly calls. The content of their treatment was based on the factors that the study found most related to failure to quit (negative affect, low motivation, low efficacy). Subjects who were abstinent at the end of the core program received seven phone cells over a three month period and then six monthly calls. The content of their treatment included efficacy and motivation building exercises as well as the continued contact for six more months than in the Control condition. Follow-up data were collected every three months for 15 months beyond the core cessation program. The hypothesis was that the Enhanced Treatment, compared with the Control, would improve rates of recycling after a failure to quit, decrease relapse rates, and increase sustained recycling following a relapse.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1989

Study Completion (Actual)

April 1, 1999

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

July 1, 2000

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4182
  • R01HL042485 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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