Clinical trial NCT01615770: Behavioral Maintenance Treatment for Smoking Cessation
Official title: Behavioral Maintenance Treatment for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-06-11
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: expired-air carbon monoxide confirmed 7-day point prevalence smoking abstinence
timeFrame: 52 weeks
Secondary outcomes:
measure: depression symptoms
timeFrame: 52 weeks
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Stanford Stop Smoking Program
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Joel D Killen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.