Extended Treatment for Smoking Cessation

Stanford University

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: Nicotine patch; Drug: Bupropion; Drug: Varenicline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01330043

R01DA017441 (U.S. NIH Grant/Contract)

SU-09272010-6949

Details and patient eligibility

About

Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment phases. Randomization. Participants will be randomized to extended therapy or control conditions at baseline (prior to open label treatment) and the analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the Supportive therapy Control treatment.

Full description

During open label treatment, all receive CBT and bupropion and nicotine patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and nicotine replacement therapy (NRT) through week 26. Medication will not be available after week 26. All will receive CBT through week 26.

Enrollment: 223 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age at least 18 years at the beginning of the study Smoking at least 10 cigarettes a day (1/2 pack)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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223 participants in 2 patient groups

Non-extended treatment

Active Comparator group

Description:

* 26 weeks of CBT * 10 weeks of combination bupropion plus nicotine patch * Additional 16 weeks of bupropion plus nicotine patch if increased craving or depression scores or varenicline if smoking at 10 weeks

Treatment:

Drug: Varenicline

Drug: Bupropion

Drug: Nicotine patch

Extended treatment

Experimental group

Description:

* 26 weeks of CBT * 10 weeks of combination bupropion plus nicotine patch * Additional 16 weeks of bupropion plus nicotine patch if increased craving or depression scores or varenicline if smoking at 10 weeks * 24 additional weeks of CBT

Treatment:

Drug: Varenicline

Drug: Bupropion

Drug: Nicotine patch