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Completed

NCT Number: NCT01330043

Extended Treatment for Smoking Cessation

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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 At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Other names: Zyban

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.

Other names: NRT

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.

Other names: Chantix

Primary outcomes

  1. Expired-air CO Verified Point-prevalence Abstinence

    Time frame: 52 weeks

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

Secondary outcomes

  1. Expired-air CO Verified Point-prevalence Abstinence

    Time frame: 104 weeks

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 6, 2011
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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