Concurrent Bupropion / Varenicline for Smoking Cessation

Browse trials for

• Tobacco Use Disorder 968

Keywords

• Nicotine addiction
• Cigarette smoking
• Smoking cessation
• Zyban
• Chantix
• Nicotine patches
• Nicotrol Inhaler
• varenicline
• bupropion

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's enrollment of 702 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Study arms

• Active comparator
  varenicline

  This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.

  Drug: Varenicline

• Active comparator
  Nicotine Patches only

  This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.

  Drug: Nicotine patches

• Active comparator
  Nicotine Patches with Nicotine Inhaler

  This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.

  Drug: Nicotine patches · Drug: Nicotine Inhaler

• Active comparator
  varenicline with bupropion

  This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.

  Drug: Varenicline · Drug: Bupropion

Interventions

• DrugVarenicline

  For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.

  Also known as: Chantix

• DrugBupropion

  For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.

  Also known as: Zyban

• DrugNicotine patches

  Nicotine Replacement Therapy Groups: 1. For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or 2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. Varenicline and varenicline in combination with bupropion groups: 1. For smokers with high baseline CO: 42 mg/24 h for 1 week 2. For smokers with low baseline CO: 21 mg/24 h for 1 week

  Also known as: Nicoderm

• DrugNicotine Inhaler

  Nicotine inhaler to use as needed after quit date

  Also known as: Nicotrol Inhaler

Primary outcomes

1. Four-week Continuous Abstinence From Cigarette Smoking

   The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.

   Time frame: Study week 8 thru week 11

Secondary outcomes

1. Seven Day Point Abstinence From Cigarette Smoking

   Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.

   Time frame: Six months post quit date

2. Continuous Cigarette Abstinence From Quit Date

   Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).

   Time frame: From Quit date to end of treatment (week 11)

Baseline characteristics

Publications

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4. PubMed 34611902 ↗
• Rose JE, Behm FM. Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm. Am J Psychiatry. 2014 Nov 1;171(11):1199-205. doi: 10.1176/appi.ajp.2014.13050595. PubMed 24934962 ↗