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Cardiovascular DiseasesNCT00005687

Recycling Attempters and Relapsers in Smoking Cessation

An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To study the process of recycling failed smoking cessation attempts and relapses. Read more about this study

Who is it for?
Ages Up to 100 years, men only
How many people
Not given
Where
No sites listed yet
Study dates
Apr 1989to Apr 1999
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

To study the process of recycling failed smoking cessation attempts and relapses.

Read the 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.

Medical subject headings
Cardiovascular Diseases, Heart Diseases, Lung Diseases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startApr 1989
  3. Study completionApr 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005687
Sponsor's protocol ID
4182
Other IDs
R01HL042485
Status last verified
Jul 2000
First submitted
25 May 2000
Last updated
29 Feb 2016
Results posted
No

Publications

  • Shadel WG, Mermelstein RJ. Cigarette smoking under stress: the role of coping expectancies among smokers in a clinic-based smoking cessation program. Health Psychol. 1993 Nov;12(6):443-50. doi: 10.1037//0278-6133.12.6.443.

    PubMed 8293727
  • Flay BR, Ockene JK, Tager IB. Smoking: epidemiology, cessation, and prevention. Task Force on Research and Education for the Prevention and Control of Respiratory Diseases. Chest. 1992 Sep;102(3 Suppl):277S-301S. doi: 10.1378/chest.102.3.277s. No abstract available.

    PubMed 1516456
  • Hedeker D, Mermelstein RJ. Application of random-effects regression models in relapse research. Addiction. 1996 Dec;91 Suppl:S211-29.

    PubMed 8997794
  • Shadel WG, Mermelstein R, Borrelli B. Self-concept changes over time in cognitive-behavioral treatment for smoking cessation. Addict Behav. 1996 Sep-Oct;21(5):659-63. doi: 10.1016/0306-4603(95)00088-7.

    PubMed 8876764
  • Borrelli B, Mermelstein R. The role of weight concern and self-efficacy in smoking cessation and weight gain among smokers in a clinic-based cessation program. Addict Behav. 1998 Sep-Oct;23(5):609-22. doi: 10.1016/s0306-4603(98)00014-8.

    PubMed 9768298

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005687, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.

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