Clincosm LogoSign in Get a demo

High Dose Bupropion for Smoking Cessation

Sponsor
University of Southern California (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03326128
Collaborator
University of California, Los Angeles (Other), University of California, San Diego (Other)
300
Enrollment
1
Location
2
Arms
38
Anticipated Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to investigate the benefit of administering Bupropion XL (BUP-XL) to heavy smokers who also experience psychiatric symptoms.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupropion hydrochloride extended release
 Phase 2

Detailed Description

Participants will be randomly assigned to either receive 300 mg of BUP-XL or 450 mg of BUP-XL with an aim to quit smoking. They will take the medication for 8 weeks while simultaneously receiving counseling to set a quit date and stay motivated to quit. Medication will be administered for 4 weeks before and 4 weeks after designated quit-date. Post-treatment follow-up appointment will be scheduled for 8, 16, and 26 weeks post treatment so assess commitment to quitting and overall success of the study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to receive either 300 or 450 mg of Bupropion XL.Participants will be randomly assigned to receive either 300 or 450 mg of Bupropion XL.
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Participant will be unaware of which medication condition they have been assigned to, the care provider will not know which dose of medication they are distributing.
Primary Purpose:
Treatment
Official Title:
High Dose Bupropion Treatment for Smoking Cessation
Anticipated Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: BUP-300

Participants will receive Bupropion hydrochloride extended release for 12 weeks and titrate to a maximum dose of 300 mg/day and will also receive standard smoking cessation counseling for 8 weeks.

Drug: Bupropion hydrochloride extended release
Antidepressant that is also effective in smoking cessation
Other Names:
  • Bupropion XL

    		•
    Experimental: BUP-450

    Participants will receive Bupropion hydrochloride extended release for 12 weeks and titrate to a maximum dose of 450 mg/day and will also receive standard smoking cessation counseling for 8 weeks.

    Drug: Bupropion hydrochloride extended release
    Antidepressant that is also effective in smoking cessation
    Other Names:
  • Bupropion XL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Point prevalence Abstinence (PPA) [change in abstinence reports will be assessed] [baseline session, 4, 8, 16, 26 weeks post quite date]

      self report of smoking status

    Secondary Outcome Measures

    1. smoking cessation milestones [baseline session, 4, 8, 16, 26 weeks post quite date]

      from smoking timeline follow back interview

    2. 29 Item Inventory of Depressive and Anxious Symptomology - general depression subscale [baseline session, 4, 8, 16, 26 weeks post quite date]

      general depression: mean score of items, range = 1-5, higher scores = more depression

    3. 29 Item Inventory of Depressive and Anxious Symptomology - social anxiety subscale [baseline session, 4, 8, 16, 26 weeks post quite date]

      social anxiety: mean score of items, range = 1-5, higher scores = more social anxiety

    4. 29 Item Inventory of Depressive and Anxious Symptomology - traumatic intrusions subscale [baseline session, 4, 8, 16, 26 weeks post quite date]

      traumatic intrusions subscale: mean score of items, range = 1-5, higher scores = more traumatic intrusions

    5. 18- item adult self report scale for Attention deficit/Hyperactivity disorder (ADHD) [baseline session, 4, 8, 16, 26 weeks post quite date]

      ADHD symptom report

    6. Snaithe-Hamilton Pleasure Scale (SHAPS) [baseline session, 4, 8, 16, 26 weeks post quite date]

      Anhedonia scale - range: 1- 4, higher scores =higher reports of pleasure, scored using a mean

    7. objective body weight [baseline session, 4, 8, 16, 26 weeks post quite date]

      via medical grade scale

    8. body adiposity via bioimpedence monitor [baseline session, 4, 8, 16, 26 weeks post quite date]

      measures body fat percentage/ BMI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • smokes >= 10 cigarettes per day for >= 2 years

    • has breath CO ppm >= 10 ppm on intake

    • Age 21 - 65

    Exclusion Criteria:

    • Past year moderate- severe DSM-5 non-tobacco substance use disorder (4+ symptoms)

    • Possible drug contraindications (Panic, bipolar, bulimia, anorexia, insomnia, suicidal ideation, alcohol withdrawal, seizures, severe hypertension, renal/hepatic impairment, angle closure glaucoma)

    • current use of other cessation medication

    • current use of e-cigarettes or other tobacco products > 2X/week

    • history of bupropion use

    • current anti-psychotic, anxiolytic, antidepressant, or psychostimulant medication use

    • currently or plan to be pregnant or breastfeeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Southern California Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California
    • University of California, Los Angeles
    • University of California, San Diego

    Investigators

    • Principal Investigator: Adam M Leventhal, PhD, University of Southern California

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Adam Leventhal, Associate Professor, University of Southern California
    ClinicalTrials.gov Identifier:
    NCT03326128
    Other Study ID Numbers:
    • 1703346
    First Posted:
    Oct 31, 2017
    Last Update Posted:
    May 20, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Adam Leventhal, Associate Professor, University of Southern California
    Bupropion XL
    Anhedonia
    Heavy Smokers
    Smoking cessation
    Additional relevant MeSH terms:
    Anhedonia
    Bupropion

    Study Results

    No Results Posted as of May 20, 2020