Bupropion for Smoking Relapse

Recruiting in Palo Alto (17 mi)

Overseen by Sharon Allen, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Minnesota

Must not be taking: Cessation aids, Antidepressants

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

Prior Safety Data

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. ^{1 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. ^{1 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.

Trial 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 (Antidepressant)
• Placebo oral tablet (Behavioural Intervention)

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+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

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 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

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

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

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

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]