Bipolar DisorderPhase 1/2NCT00593099
A Preliminary Study of Sustained-Release Bupropion for Smoking Cessation in Bipolar Affective Disorder
A Phase 1/2 study testing Bupropion in people with Bipolar Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine the safety and potential efficacy of sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients with bipolar affective illness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jun 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SCID for DSM-IV diagnoses of bipolar I or bipolar II disorder, and nicotine dependence.
- Young Mania Rating Scale Total Score <12 at study entry.
- BPRS Total Score < 20 at study entry
- HAM-D 17-Item Score >12 and <25 at study entry. NB: We have set an upper limit for allowable HAM-D 17-item scores since higher scores would typically trigger the initiation of an antidepressant trial, and this study involves a placebo-controlled augmentation of existing medication therapies with bupropion.
- Fagerstrom Test for Nicotine Dependence (FTND) score of 4 or more.
- Smoking at least 15 cigarettes per day, and have expired breath CO level >10 ppm and plasma cotinine level >150 ng/ml at baseline.
- Be on a stable dose of a mood stabilizer for at least 1 month (e.g. lithium, valproate, carbamazepine, atypical antipsychotic) as judged by the study psychiatrists (T. George, M.D. and H. Blumberg, M.D.), and judged by well-trained trained psychiatric clinicians (e.g. J. Vessicchio, M.S.W. or K. Sacco, Psy.D.) to be in remission from active manic, hypomanic, major depression and psychotic symptoms based on a clinical interview and SCID-IV.
- Be able to provide informed consent to participate in this study as judged by clinical evaluation, and scoring at least 80% on a post-consent "test".
Who cannot join
- Meet criteria for current abuse or dependence for any other alcohol or illicit substance within the past 3 months of study enrollment.
- Current evidence by SCID-IV and clinical evaluation of suicidality, homocidality or psychosis.
- Meet DSM-IV criteria for current major depression at the time of baseline evaluation.
- A history of hypersensitivity or other known adverse reactions (e.g. hyperstimulation, severe agitation) to bupropion.
- Any serious documented medical disorders which might be contraindicated with bupropion (i.e. anorexia or bulimia nervosa, history of seizure disorder, history of major head injury with loss of consciousness for a period greater than five minutes), or if the results of psychiatric/medical screening suggest reason concern of a trial of bupropion (e.g., a history of severe cardiac, renal or hepatic disease, diabetes mellitus or thyroid abnormalities which in the opinion of the study internist Dr. Lynn Sullivan would preclude participation in this study).
- Evidence of clinically significant EKG abnormalities as judged by the study internist, Lynn E. Sullivan, M.D. (Department of Internal Medicine, YUSM), or her designate.
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- Prescription of monoamine oxidase inhibitors or the Wellbutrin® formulation of bupropion.
- The presence of manic, mixed manic or hypomanic symptoms in the past one (1) month prior to study enrollment.
- A lifetime history of antidepressant-induced mania or hypomania.
- A history of suicidal ideation while taking antidepressants.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
The purpose of this pilot study is to determine the safety and potential efficacy of sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients with bipolar affective illness. It is hypothesized that bupropion will produce a significant enhancement of smoking abstinence compared to placebo and will be safe for use in these patients.
Read the detailed description
The purpose of this pilot study is to determine the safety and potential efficacy of sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients with bipolar affective illness. we propose to conduct a preliminary study of the safety and efficacy of bupropion SR (with flexible dosing up to 300 mg/day) in comparison to placebo in medication-maintained and stabilized outpatients with bipolar I and II disorder who are currently depressed despite mood-stabilizing medication and who are also nicotine-dependent cigarette smokers, and who are motivated to quit smoking. Subjects will be n=32 subjects between 18 and 65 years of age who meet DSM-IV criteria for bipolar disorder (either Type I or II), and nicotine dependence, and smoke at least 15 cigarettes per day, with an FTND score at baseline >5, expired breath CO >10, and plasma cotinine >150 ng/ml, and are motivated to quit smoking within thirty days of the initial intake. Subjects must be on a stable dose of a mood stabilizer (e.g. lithium, valproate, carbamezepine, topiramate, gabapentin or atypical antipsychotic), and be in complete remission from active manic or hypomanic and psychotic symptoms as judged by a psychiatric evaluation. Subjects will be recruited through outpatient departments at Connecticut Mental Health Center (CMHC) and its satellite clinics. Study medications will be given for 9 weeks duration, beginning at 1 week prior to the "quit date". Bupropion [as the intermediate-release (IR) formulation] will begin at 75 mg po qd x 3days, then increase to 150 mg [as bupropion SR formulation] qd x 4 days, and then increased to a final dose of up to 150 mg po bid (300 mg/day) by Day 15 (the target quit date; TQD) as tolerated, and this dose will be continued for an additional eight (8) weeks at up to 150 mg po bid. We will allow flexible dosing above 150 mg/day to allow for adjustments needed if a bipolar subject does not tolerate the full dose of Zyban at 300 mg/day. Zyban will then be discontinued at the end of Week 10. Primary outcome measures are endpoint (7-day) smoking abstinence and adverse events.
- Conditions
- Bipolar Disorder
- Being tested
- Bupropion, Placebo
- Keywords
- Bipolar Disorder, Nicotine Dependence, Smoking Cessation, Bupropion, sustained-release
- Medical subject headings
- Bipolar Disorder, Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Zyban
BUP [as the intermediate-release (IR) formulation] was inducted on Day 1 of the trial at 75 mg po qd x 3 days, then increased to 150 mg [as BUP SR formulation] qd x 4 days, and then increased to a final dose of up to 150 mg po bid (300 mg/day) by Day 15 (target quit date; TQD) as tolerated. This dose was continued for an additional eight (8) weeks at up to 150 mg po bid. Flexible dosing was permitted to allow for adjustments needed if a bipolar subject did not tolerate the full dose of BUP at 300 mg/day. BUP was discontinued at the end of Week 10.
PlaceboDrug
matching placebo capsules (PLA) containing only a dextrose matrix.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Buproprion Receives: Drug: Bupropion |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: End of Trial
Secondary outcomes (1)
Smoking abstinence [7-day point prevalence at end of trial (EOT)]
Measured: End of Trial (7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startApr 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Tony P. George, M.D., FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593099
- Sponsor's protocol ID
- 26254
- Status last verified
- Dec 2007
- First submitted
- 28 Dec 2007
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study of Sustained-Release Bupropion for Smoking Cessation in Bipolar Affective Disorder
- ClinicalTrials.gov ID
- NCT00593099
- Acronym / sponsor ID
- 26254
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Nicotine Dependence, Smoking Cessation, Bupropion, sustained-release
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Apr 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to determine the safety and potential efficacy of sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients with bipolar affective illness. It is hypothesized that bupropion will produce a significant enhancement of smoking abstinence compared to placebo and will be safe for use in these patients.
Detailed description
The purpose of this pilot study is to determine the safety and potential efficacy of sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients with bipolar affective illness. we propose to conduct a preliminary study of the safety and efficacy of bupropion SR (with flexible dosing up to 300 mg/day) in comparison to placebo in medication-maintained and stabilized outpatients with bipolar I and II disorder who are currently depressed despite mood-stabilizing medication and who are also nicotine-dependent cigarette smokers, and who are motivated to quit smoking. Subjects will be n=32 subjects between 18 and 65 years of age who meet DSM-IV criteria for bipolar disorder (either Type I or II), and nicotine dependence, and smoke at least 15 cigarettes per day, with an FTND score at baseline >5, expired breath CO >10, and plasma cotinine >150 ng/ml, and are motivated to quit smoking within thirty days of the initial intake. Subjects must be on a stable dose of a mood stabilizer (e.g. lithium, valproate, carbamezepine, topiramate, gabapentin or atypical antipsychotic), and be in complete remission from active manic or hypomanic and psychotic symptoms as judged by a psychiatric evaluation. Subjects will be recruited through outpatient departments at Connecticut Mental Health Center (CMHC) and its satellite clinics. Study medications will be given for 9 weeks duration, beginning at 1 week prior to the "quit date". Bupropion [as the intermediate-release (IR) formulation] will begin at 75 mg po qd x 3days, then increase to 150 mg [as bupropion SR formulation] qd x 4 days, and then increased to a final dose of up to 150 mg po bid (300 mg/day) by Day 15 (the target quit date; TQD) as tolerated, and this dose will be continued for an additional eight (8) weeks at up to 150 mg po bid. We will allow flexible dosing above 150 mg/day to allow for adjustments needed if a bipolar subject does not tolerate the full dose of Zyban at 300 mg/day. Zyban will then be discontinued at the end of Week 10. Primary outcome measures are endpoint (7-day) smoking abstinence and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BupropionBuproprion |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- SCID for DSM-IV diagnoses of bipolar I or bipolar II disorder, and nicotine dependence.
- Young Mania Rating Scale Total Score <12 at study entry.
- BPRS Total Score < 20 at study entry
- HAM-D 17-Item Score >12 and <25 at study entry. NB: We have set an upper limit for allowable HAM-D 17-item scores since higher scores would typically trigger the initiation of an antidepressant trial, and this study involves a placebo-controlled augmentation of existing medication therapies with bupropion.
- Fagerstrom Test for Nicotine Dependence (FTND) score of 4 or more.
Key exclusion criteria (10 listed)
- Meet criteria for current abuse or dependence for any other alcohol or illicit substance within the past 3 months of study enrollment.
- Current evidence by SCID-IV and clinical evaluation of suicidality, homocidality or psychosis.
- Meet DSM-IV criteria for current major depression at the time of baseline evaluation.
- A history of hypersensitivity or other known adverse reactions (e.g. hyperstimulation, severe agitation) to bupropion.
- Any serious documented medical disorders which might be contraindicated with bupropion (i.e. anorexia or bulimia nervosa, history of seizure disorder, history of major head injury with loss of consciousness for a period greater than five minutes), or if the results of psychiatric/medical screening suggest reason concern of a trial of bupropion (e.g., a history of severe cardiac, renal or hepatic disease, diabetes mellitus or thyroid abnormalities which in the opinion of the study internist Dr. Lynn Sullivan would preclude participation in this study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionAlso: ZybanBUP [as the intermediate-release (IR) formulation] was inducted on Day 1 of the trial at 75 mg po qd x 3 days, then increased to 150 mg [as BUP SR formulation] qd x 4 days, and then increased to a final dose of up to 150 mg po bid (300 mg/day) by Day 15 (target quit date; TQD) as tolerated. This dose was continued for an additional eight (8) weeks at up to 150 mg po bid. Flexible dosing was permitted to allow for adjustments needed if a bipolar subject did not tolerate the full dose of BUP at 300 mg/day. BUP was discontinued at the end of Week 10. | Drug | 1 |
| Placebomatching placebo capsules (PLA) containing only a dextrose matrix. | Drug | 2 |
Primary outcome
Adverse Events
Time frame: End of Trial
1 secondary outcome
Smoking abstinence [7-day point prevalence at end of trial (EOT)]
Time frame: End of Trial (7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony P. George, M.D., FRCPC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bupropion in people with Bipolar Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: End of Trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.