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

Trial Summary

What is the purpose of this trial?

This two-arm, double-blind, placebo-controlled randomized clinical trial will enroll pregnant women who quit smoking after learning they were pregnant and are motivated to stay abstinent postpartum. Participants will be randomized to receive extended-release bupropion (active 300mg or placebo once daily beginning 4 to 10 days postpartum to 12 weeks post-randomization). All participants will complete the same data collection procedures (e.g., biological sample collection for hormone and cotinine analysis and completion of validated questionnaires) at baseline (gestational week 36), weekly from 4 to 10 days postpartum through 12 weeks post-randomization and at weeks 12, 24, 36 and 52 post-randomization.

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 data supports the effectiveness of the drug Bupropion Extended Release Oral Tablet for preventing smoking relapse?

Research shows that Bupropion Extended Release can significantly help people quit smoking, especially women and those with a history of depression, by tripling their chances of staying smoke-free for a year compared to a placebo. It also reduces cravings and withdrawal symptoms, making it easier for smokers to quit. ^{1 2 3 4 5}

Is bupropion safe for humans?

Bupropion sustained release (SR) is generally considered safe for humans, with studies showing it has an excellent adverse effect profile. However, there is a risk of serious side effects like seizures, which can be minimized by carefully selecting patients. ^{2 4 6 7 8}

How does the drug Bupropion differ from other treatments for smoking relapse?

Bupropion is unique because it is a non-nicotine-based prescription drug that can be started before quitting smoking, and it has been shown to be particularly effective for women and individuals with a history of depression, tripling non-smoking rates compared to a placebo. ^{2 3 4 9 10}

Research Team

Sharon Allen, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A multicentre, randomized, double-blind, placebo-controlled, 1-year study of bupropion SR for smoking cessation. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Targeting smokers at increased risk for relapse: treating women and those with a history of depression. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of sustained-release bupropion among persons interested in reducing but not quitting smoking. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of bupropion sustained-release for preventing tobacco relapse in recovering alcoholics. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Effect of sustained-release (SR) bupropion on craving and withdrawal in smokers deprived of cigarettes for 72 h. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Varenicline and bupropion sustained-release combination therapy for smoking cessation. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Bupropion sustained release for treatment of tobacco dependence. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

The effect of bupropion sustained-release on cigarette craving after smoking cessation. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Does bupropion have advantages over other medical therapies in the cessation of smoking? [2019]