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High Dose Bupropion for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326128
Recruitment Status : Not yet recruiting
First Posted : October 31, 2017
Last Update Posted : May 20, 2020
Sponsor:
Collaborators:
University of California, Los Angeles
University of California, San Diego
Information provided by (Responsible Party):
Adam Leventhal, University of Southern California

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
Smoking Cessation Smoking, Tobacco Smoking (Tobacco) Addiction Cessation, Tobacco Anhedonia 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Bupropion XL




Primary Outcome Measures :
  1. Point prevalence Abstinence (PPA) [change in abstinence reports will be assessed] [ Time Frame: baseline session, 4, 8, 16, 26 weeks post quite date ]
    self report of smoking status


Secondary Outcome Measures :
  1. smoking cessation milestones [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: baseline session, 4, 8, 16, 26 weeks post quite date ]
    ADHD symptom report

  6. Snaithe-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 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 [ Time Frame: baseline session, 4, 8, 16, 26 weeks post quite date ]
    via medical grade scale

  8. body adiposity via bioimpedence monitor [ Time Frame: baseline session, 4, 8, 16, 26 weeks post quite date ]
    measures body fat percentage/ BMI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326128


Contacts
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Contact: Lauren Whitted, MA 323-442-1197 lwhitted@usc.edu

Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Contact: Lauren Whitted, MA    323-442-1197    lwhitted@usc.edu   
Sponsors and Collaborators
University of Southern California
University of California, Los Angeles
University of California, San Diego
Investigators
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Principal Investigator: Adam M Leventhal, PhD University of Southern California
  Study Documents (Full-Text)

Documents provided by Adam Leventhal, University of Southern California:
Informed Consent Form: MAIN ICF  [PDF] September 22, 2017
Informed Consent Form: PILOT ICF  [PDF] September 22, 2017

Publications:

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Responsible Party: Adam Leventhal, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03326128    
Other Study ID Numbers: 1703346
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adam Leventhal, University of Southern California:
Bupropion XL
Anhedonia
Heavy Smokers
Smoking cessation
Additional relevant MeSH terms:
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Anhedonia
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors