Behavioral Maintenance Treatment for Smoking Cessation

NCT ID: NCT01615770

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2009-06-30

Brief Summary

Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. The investigators will also conduct secondary analyses of mediators and moderators of treatment response.

Detailed Description

400 adult smokers will be randomized. Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. All smokers will receive the same "Acute Phase Treatment" that combines nicotine patch, bupropion and intensive self-regulatory skills training. Nicotine patches will be provided for 8 weeks and bupropion and skills training will be provided for of 9 weeks. Participants will then enter a "Maintenance Treatment Phase" during which half (n=200) will receive three individualized relapse prevention training sessions spread over a 12 week period. They will also receive 12 weeks of self-administered RPT administered via written treatment modules. Finally, telephone counseling will be provided in conjunction with an Interactive Voice Response system (IVR) that will allow early detection of smoking "slips" and rapid response by treatment staff. The other half (n=200) will be assigned to a control condition that consists of three counselor-led sessions of "supportive therapy" spread over a 12 week period.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Open Label CBT and Pharmacotherapy

All study participants received 8 weeks of cognitive and behavioral cessation and relapse prevention skills training (CBT) and nicotine patch therapy combined with 9 weeks of bupropion SR therapy. Following open-label, this group received general supportive therapy delivered via four telephone calls made to participants over a 12-week period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Behavioral: cognitive behavior therapy

All study participants received 8 weeks of cognitive and behavioral cessation and relapse prevention skills training (CBT) and nicotine patch therapy combined with 9 weeks of bupropion SR therapy. Following open-label treatment, half the participants received an additional 12 weeks of CBT that combined clinic-based skills training sessions, voicemail monitoring and telephone counseling

Group Type: EXPERIMENTAL

cognitive behavior therapy

Intervention Type: BEHAVIORAL

At each clinic session, staff met with participants individually for 30 minutes to develop cognitive and behavioral skills to resist urges to smoke. Staff used self-efficacy questionnaires to assess participants' confidence in their abilities to resist urges to smoke in specific situations and behavioral worksheets to help participants articulate treatment plans to be used in managing their behavior in these situations without smoking. Those participants randomized to extended CBT continued to work with treatment staff individually on the development and use of cognitive and behavioral cessation and relapse prevention skills. Treatment sessions, lasting approximately 30 minutes, were conducted at the San Jose clinic site at weeks 8, 12, 16 and 20.

Interventions

cognitive behavior therapy

At each clinic session, staff met with participants individually for 30 minutes to develop cognitive and behavioral skills to resist urges to smoke. Staff used self-efficacy questionnaires to assess participants' confidence in their abilities to resist urges to smoke in specific situations and behavioral worksheets to help participants articulate treatment plans to be used in managing their behavior in these situations without smoking. Those participants randomized to extended CBT continued to work with treatment staff individually on the development and use of cognitive and behavioral cessation and relapse prevention skills. Treatment sessions, lasting approximately 30 minutes, were conducted at the San Jose clinic site at weeks 8, 12, 16 and 20.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Healthy adult cigarette smokers smoking at least 10 cigarettes per day

Exclusion Criteria

• Currently pregnant
• Currently breastfeeding
• Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure
• History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
• Family history of seizures
• Currently using intravenous drugs
• Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
• Currently using any over-the-counter stimulants and anorectics (diet pills)
• Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
• Currently on NRT or bupropion (Zyban)
• Current or past diagnosis of anorexia nervosa or bulimia nervosa
• Previous allergic response to bupropion or NRT
• Previous failed quit attempt using NRT and bupropion in combination

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Joel D Killen

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel D Killen

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Stop Smoking Program

San Jose, California, United States

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Bailey SR, Hammer SA, Bryson SW, Schatzberg AF, Killen JD. Using treatment process data to predict maintained smoking abstinence. Am J Health Behav. 2010 Nov-Dec;34(6):801-10. doi: 10.5993/ajhb.34.6.14.

Reference Type: BACKGROUND

PMID: 20604703 (View on PubMed)

Killen JD, Fortmann SP, Schatzberg AF, Arredondo C, Murphy G, Hayward C, Celio M, Cromp D, Fong D, Pandurangi M. Extended cognitive behavior therapy for cigarette smoking cessation. Addiction. 2008 Aug;103(8):1381-90. doi: 10.1111/j.1360-0443.2008.02273.x.

Reference Type: RESULT

PMID: 18855829 (View on PubMed)

Other Identifiers

R01DA017441

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SU-09282010-6951

Identifier Type: -

Identifier Source: org_study_id