Bupropion for the Prevention of Postpartum Smoking Relapse

Conditions

• Postpartum Smoking Relapse

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• Bupropion Extended Release Oral Tablet — DRUG
  12 weeks postpartum of blinded study medication
• Placebo oral tablet — DRUG
  12 weeks postpartum of blinded placebo

Study Details

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.

Key Dates

Start date

Jan 1, 2020

Status verified

Jan 2026

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Bupropion
  Participants randomized to extended-release bupropion. Once-daily
• Placebo Comparator: Placebo
  Participants randomized to placebo. Once-daily

Primary Outcome Measure

Point prevalence smoking abstinence [ Time Frame: 24 weeks post randomization ]

Central Contacts

• Katherine Harrison, MPH
  612-624-5377
  [email protected]

Locations (1)

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