Clinical trial NCT01330043: Extended Treatment for Smoking Cessation
Official title: Extended Treatment for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: smoking cessation intervention
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-04-06
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to extended or non-extended treatment and followed for 104 weeks.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications.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.

Eligibility criteria: 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

Primary outcomes:
measure: Expired-air CO Verified Point-prevalence Abstinence
timeFrame: 52 weeks
Secondary outcomes:
measure: Expired-air CO Verified Point-prevalence Abstinence
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Sean P. David, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leyro TM, Crew EE, Bryson SW, Lembke A, Bailey SR, Prochaska JJ, Henriksen L, Fortmann SP, Killen JD, Killen DT, Hall SM, David SP. Retrospective analysis of changing characteristics of treatment-seeking smokers: implications for further reducing smoking prevalence. BMJ Open. 2016 Jun 29;6(6):e010960. doi: 10.1136/bmjopen-2015-010960.
citation: Laude JR, Bailey SR, Crew E, Varady A, Lembke A, McFall D, Jeon A, Killen D, Killen JD, David SP. Extended treatment for cigarette smoking cessation: a randomized control trial. Addiction. 2017 Aug;112(8):1451-1459. doi: 10.1111/add.13806. Epub 2017 May 2.