Behavioral Maintenance Treatment for Smoking Cessation

Stanford University

Status: Completed

Conditions: Smoking

Treatments: Behavioral: cognitive behavior therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01615770

SU-09282010-6951

R01DA017441 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

304 participants in 2 patient groups

Open Label CBT and Pharmacotherapy

No Intervention group

Description:

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.

Behavioral: cognitive behavior therapy

Experimental group

Description:

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

Treatment:

Behavioral: cognitive behavior therapy