A Preliminary Study of Sustained-Release Bupropion for Smoking Cessation in Bipolar Affective Disorder

NCT00593099 | Completed Phase 1

• 1 other identifier: 26254
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Nicotine Dependence; Smoking Cessation; Bupropion, sustained-release

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  End of Trial

Secondary Outcomes (1)

• Smoking abstinence [7-day point prevalence at end of trial (EOT)]

  End of Trial (7 days)

Study Arms (2)

1

EXPERIMENTAL

Buproprion

Drug: Bupropion

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Bupropion DRUG

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.

Also known as: Zyban

1

Placebo DRUG

matching placebo capsules (PLA) containing only a dextrose matrix.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Tobacco Use Disorder; Smoking Cessation

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Tony P. George, M.D., FRCPC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 14, 2008
• Study Start: April 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: January 11, 2017

Record last verified: 2007-12

Locations

US (1)