Extended Treatment for Smoking Cessation

NCT01330043 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: SU-09272010-6949R01DA017441
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

smoking cessation intervention

Outcome Measures

Primary Outcomes (1)

• Expired-air CO Verified Point-prevalence Abstinence

  Self-reported no smoking in last 7 days verified by CO\<10 ppm

  52 weeks

Secondary Outcomes (1)

• Expired-air CO Verified Point-prevalence Abstinence

  104 weeks

Study Arms (2)

Non-extended treatment

ACTIVE COMPARATOR

* 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

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

Extended treatment

EXPERIMENTAL

* 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

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

Interventions

Bupropion DRUG

Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.

Also known as: Zyban

Extended treatment; Non-extended treatment

Nicotine patch DRUG

Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.

Also known as: NRT

Extended treatment; Non-extended treatment

Varenicline DRUG

Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.

Also known as: Chantix

Extended treatment; Non-extended treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Currently pregnant
• Currently breastfeeding
• Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure or diabetes mellitus
• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 27357195 BACKGROUND

• 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.

  PMID: 28239942 RESULT

MeSH Terms

Conditions

Smoking Cessation

Interventions

Bupropion; Tobacco Use Cessation Devices; Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Therapeutics; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

The target sample size of N=400 was not reached due to challenges with recruitment, however, the sample size achieved was sufficient to test main effects of extended treatment on abstinence outcomes.

Results Point of Contact

• Title: Dr. Sean P. David
• Organization: Stanford University

spdavid@stanford.edu

401-265-2275

Study Officials

• Sean P. David, MD, DPhil

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Behavioral therapists were blinded until the end of open-label treatment (26 weeks). Investigators were blinded to treatment assignment until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomized to extended or non-extended treatment and followed for 104 weeks.

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: April 6, 2011
• Study Start: March 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 1, 2017
• Results First Posted: August 1, 2017

Record last verified: 2017-07

Locations

US (1)