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CompletedNCT00005687Updated Feb 29, 2016

Recycling Attempters and Relapsers in Smoking Cessation

An observational study in Cardiovascular Diseases, Heart Diseases and Lung Diseases, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed. Open to male participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2016-02-29.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Ages
Up to 100 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
  • Lung Diseases
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

Browse Cardiovascular Diseases studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 72 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 50 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

No eligibility criteria

05

Study design

06

Study locations

No study locations are listed for this record.

07

References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 1989 and a completion of Apr 1999. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2000
First posted
May 26, 2000
Start
Apr 1989
CompletionActual
Apr 1999
Last update
Feb 29, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00005687
First posted
May 26, 2000
Start date
Apr 1989
Completion
Apr 1999
Last update
Feb 29, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2000. You cannot join it, but the record below documents what was studied.

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