Bupropion for Smoking Relapse

Overseen By Katherine Harrison, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Minnesota

Must not be taking: Cessation aids, Antidepressants

Disqualifiers: Tobacco use, Illicit drugs, Seizure disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if bupropion, a medication, can help new mothers remain smoke-free after childbirth. The study will compare bupropion to a placebo (a pill with no active ingredient) to assess its effectiveness. It seeks women who quit smoking during pregnancy, intend to remain smoke-free, and have stable health conditions. Participants will take the medication or placebo once daily and provide samples and complete questionnaires throughout the study. This research could identify better ways to support new mothers in staying smoke-free. As a Phase 4 trial, it involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as antidepressants and any medications that might increase the risk of taking bupropion. If you're on these medications, you would need to stop them to participate.

What is the safety track record for bupropion extended-release oral tablet?

Research has shown that bupropion is generally well-tolerated and can help people quit smoking. In studies, individuals using bupropion were about twice as likely to stop smoking compared to those taking a placebo, indicating its effectiveness and safety for many users. However, some have reported side effects such as mood changes or trouble sleeping.

Bupropion has been used in other forms to aid smoking cessation and is already approved for this purpose, having undergone thorough safety testing. Nonetheless, discussing potential side effects with a healthcare provider remains important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Bupropion is unique because it targets smoking relapse by acting on the brain's neurotransmitters, specifically affecting norepinephrine and dopamine. Unlike nicotine replacement therapies, which primarily tackle the physical addiction to nicotine, bupropion addresses the psychological aspects of addiction. Researchers are excited about this treatment because its extended-release formulation allows for more consistent blood levels, which may enhance its effectiveness in preventing smoking relapse. This makes it a promising option for those looking to maintain long-term smoking cessation.

What evidence suggests that bupropion might be an effective treatment for smoking relapse?

Research has shown that bupropion, which participants in this trial may receive, can help people quit smoking. Studies have found that bupropion can nearly double the chances of quitting compared to a placebo, which contains no active medicine. In one study, 27% of people using bupropion were not smoking after 26 weeks, while only 11% of those taking a placebo had quit. Another study found that 51.1% of postpartum women who used bupropion were smoke-free after a year, compared to 42.3% of those who took a placebo. These findings suggest that bupropion can help people remain smoke-free for longer, even after having a baby. Participants in this trial will receive either bupropion or a placebo to evaluate its effectiveness in preventing smoking relapse. ^{2 4 6 7 8}

Who Is on the Research Team?

Sharon Allen, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for women aged 18-40 who quit smoking during pregnancy, had a full-term and uncomplicated delivery, and are motivated to avoid smoking postpartum. They must not plan to get pregnant again soon, use other tobacco or cessation aids, have certain mental health conditions or take medications that could interact with the trial drug.

Inclusion Criteria

Full-term delivery ≥ 37 weeks gestation

My health condition is stable.

Denies plans to become pregnant again during the trial.

Exclusion Criteria

My newborn is at high risk for seizures.

I have a condition or take medication that may not mix well with bupropion.

I am currently taking antidepressant medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline data collection at gestational week 36

1 week

1 visit (in-person)

Treatment

Participants receive extended-release bupropion or placebo from 4 to 10 days postpartum to 12 weeks post-randomization

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for smoking abstinence and complete data collection at weeks 12, 24, 36, and 52 post-randomization

52 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bupropion Extended Release Oral Tablet
• Placebo oral tablet

Trial Overview The study tests if Bupropion can prevent new moms from starting to smoke again after giving birth. Half will receive Bupropion and half a placebo (a dummy pill), without knowing which one they're taking. The treatment starts shortly after childbirth and continues for 12 weeks.

How Is the Trial Designed?

Group I: Bupropion Experimental Treatment 1 Intervention

Participants randomized to extended-release bupropion. Once-daily

Group II: Placebo Placebo Group 1 Intervention

Participants randomized to placebo. Once-daily

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Bupropion sustained-release (SR) significantly increased 1-year non-smoking rates among female smokers and those with a history of depression, tripling their chances of successful cessation compared to a placebo.

In contrast, the nicotine patch did not show a significant improvement in smoking cessation rates for any subgroup, highlighting bupropion SR as a more effective first-line treatment for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting smokers at increased risk for relapse: treating women and those with a history of depression. Smith, SS., Jorenby, DE., Leischow, SJ., et al.[2022]

In a Phase II clinical trial with 38 smokers, combination therapy using varenicline and bupropion SR resulted in a 71% smoking abstinence rate at 3 months, indicating high efficacy for tobacco dependence treatment.

The combination therapy was generally safe, with common side effects being sleep disturbances and nausea, but no increase in depressive symptoms or suicidal ideation was reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline and bupropion sustained-release combination therapy for smoking cessation. Ebbert, JO., Croghan, IT., Sood, A., et al.[2015]

Bupropion sustained-release (SR) is an effective prescription treatment for smoking cessation, and it is unique because it is initiated before the smoker actually quits, helping to prepare them for the process.

The effectiveness of bupropion SR has been demonstrated across various patient groups, including those with chronic diseases and different demographics, indicating its broad applicability in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does bupropion have advantages over other medical therapies in the cessation of smoking? Tonstad, S., Johnston, JA.[2019]

In a study involving participants who had stopped smoking using bupropion sustained-release (SR), those continuing with bupropion SR reported significantly lower cravings compared to those on placebo, which may help reduce relapse rates.

Craving was a major factor in relapse, with 49.2% of participants on placebo citing it as a reason for returning to smoking, compared to only 22.4% of those on bupropion SR, highlighting the efficacy of bupropion SR in managing cravings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of bupropion sustained-release on cigarette craving after smoking cessation. Durcan, MJ., Deener, G., White, J., et al.[2019]

In a study involving 195 abstinent alcoholic smokers, treatment with bupropion sustained-release (SR) did not significantly improve smoking abstinence rates compared to a placebo, with both groups showing similar outcomes at 52 weeks.

Only 4% of participants relapsed to alcohol during the study, indicating that while bupropion SR was ineffective for smoking cessation, the overall alcohol relapse rate remained low among the subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of bupropion sustained-release for preventing tobacco relapse in recovering alcoholics. Hays, JT., Hurt, RD., Decker, PA., et al.[2021]

Bupropion sustained release (SR) is an effective nonnicotine medication for tobacco dependence, shown to double abstinence rates compared to placebo in randomized controlled trials.

While bupropion SR has a favorable safety profile, there is a risk of serious adverse effects like seizures, which can be minimized through careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupropion sustained release for treatment of tobacco dependence. Hays, JT., Ebbert, JO.[2013]

Sustained-release (SR) bupropion significantly reduced cigarette craving and appetite increase during periods of smoking abstinence in a study involving 23 smokers over 17 days.

The study found that while SR bupropion helped lower craving intensity compared to placebo, overall withdrawal symptoms were still less severe when participants were allowed to smoke freely, suggesting that different mechanisms may control craving and withdrawal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of sustained-release (SR) bupropion on craving and withdrawal in smokers deprived of cigarettes for 72 h. Teneggi, V., Tiffany, ST., Squassante, L., et al.[2022]

In a study of 222 smokers who did not significantly reduce their smoking with nicotine patches, the combination of varenicline and bupropion led to a higher abstinence rate (39.8%) compared to varenicline plus placebo (25.9%).

The combination treatment was particularly effective for male smokers and those with high nicotine dependence, suggesting it may be a better option for these groups when initial nicotine patch treatment fails.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm. Rose, JE., Behm, FM.[2022]

Sustained-release bupropion significantly increased short-term smoking abstinence rates during treatment (14% vs. 8% for placebo), helping smokers who were initially unwilling to quit.

While bupropion promoted smoking reduction and reduced the time to the next cessation attempt, these benefits were not maintained after the medication was stopped, indicating that its effects are temporary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sustained-release bupropion among persons interested in reducing but not quitting smoking. Hatsukami, DK., Rennard, S., Patel, MK., et al.[2019]

In a study involving 707 smokers, bupropion sustained release (SR) combined with counseling significantly increased smoking cessation rates, with a continuous abstinence rate of 46% compared to 23% for placebo during weeks 4 to 7.

At the 12-month mark, the continuous abstinence rate was 21% for the bupropion SR group versus 11% for placebo, indicating long-term effectiveness, although some participants experienced higher rates of side effects like insomnia and dry mouth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicentre, randomized, double-blind, placebo-controlled, 1-year study of bupropion SR for smoking cessation. Tønnesen, P., Tonstad, S., Hjalmarson, A., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2528204/

The use of bupropion SR in cigarette smoking cessation In patients with established CVD, bupropion has similar success rates compared with healthy smokers (27% bupropion vs 11% placebo at 26 weeks, 22% vs 9% at 52 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421000884

Bupropion for postpartum smoking relapse placebo showed 7-day point prevalence abstinence rates of 51.1% vs. 42.3% (p < 0.01) at 52-weeks and 47.7% vs. 37.7% (p < 0.05) at 78-weeks.

3. nejm.org nejm.org/doi/full/10.1056/NEJM199710233371703

A Comparison of Sustained-Release Bupropion and ... A sustained-release form of bupropion was effective for smoking cessation and was accompanied by reduced weight gain and minimal side effects.

4. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(11)63149-2/fulltext

Bupropion Sustained Release for Treatment of Tobacco ... Long-term treatment with bupropion SR may reduce or delay smoking relapse. Bupropion SR has an excellent adverse effect profile, although a risk exists for ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2012.08.1030

Bupropion for Smoking Cessation in Patients Hospitalized ... Bupropion approximately doubles quit rates in otherwise healthy smokers and patients with stable cardiovascular disease (5,7), but its efficacy ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/021515s043lbl.pdf

Wellbutrin XL - accessdata.fda.gov Wellbutrin XL is not approved for smoking cessation treatment; however, bupropion HCl sustained-release is approved for this use. Serious neuropsychiatric ...

7. cdc.gov cdc.gov/tobacco/campaign/tips/quit-smoking/quit-smoking-medications/how-to-use-quit-smoking-medicines/how-to-use-bupropion-sr.html

How to Use Bupropion SR | Quit Smoking Bupropion is a pill you take twice a day. You start it 1-2 weeks before quitting. It does not contain nicotine, so it works differently than nicotine ...

8. goodrx.com goodrx.com/zyban/what-is?srsltid=AfmBOooh1cXy2iD0JalILo_vS3xgtN4pt8DHGMPuSjAquyC0Jt6o6tpx

Bupropion (Zyban): Uses, Side Effects, Dosage & More Bupropion extended-release (SR), brand name Zyban, is an atypical antidepressant. It's taken by adults for smoking cessation (quitting smoking) only.