Behavioral Maintenance Treatment for Smoking Cessation

Smoking Clinical Trial

Official title:

Behavioral Maintenance Treatment for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615770
• Other study ID #: SU-09282010-6951
• Secondary ID: R01DA017441
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: March 1, 2016
• Start date: February 2004
• Est. completion date: June 2009

Study information

• Verified date: March 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: June 2009
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Stanford Stop Smoking Program	San Jose	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expired-air carbon monoxide confirmed 7-day point prevalence smoking abstinence	expired-air carbon monoxide < 10 ppm and self report of no smoking for 7 consecutive days prior to assessment	52 weeks	No
Secondary	depression symptoms	symptoms of depression measured with the CES-D	52 weeks	No