NCT00304707

Brief Summary

Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

May 15, 2017

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

4.8 years

First QC Date

March 17, 2006

Results QC Date

April 5, 2017

Last Update Submit

May 4, 2017

Conditions

Smoking CessationAlcohol-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • Smoking Abstinence

    The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.

    week 7, week 11 and week 24 after scheduled quit day

Study Arms (2)

2

EXPERIMENTAL

participants in this arm receive bupropion

Drug: Bupropion

1

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

BupropionDRUG

300 mg QD

2
placeboDRUG

placebo

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokes a minimum of 10 cigarettes daily for at least 1 year prior to study entry
  • Abstinence from alcohol and other non-nicotine drugs for between 1 and 12 months at time of study entry
  • Meets criteria for alcohol dependence or abuse in the 12 months prior to study entry

You may not qualify if:

  • History of seizures, head trauma and/or severe hepatic cirrhosis
  • Current use of medications known to affect smoking behavior and/or cessation
  • Use of tricyclic antidepressant medication and monoamine oxidase inhibitors
  • Major depressive disorder within the month prior to study entry
  • Eating disorder within the year prior to study entry
  • History of bipolar or psychotic disorder
  • Pregnant or breastfeeding
  • Unstable serious medical disorder
  • History of migraines
  • Currently using smokeless tobacco, pipes, or cigars

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ENRM Veterans Hospital

Bedford, Massachusetts, 01730, United States

Location

Related Publications (1)

  • Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

    PMID: 37230961DERIVED

MeSH Terms

Conditions

Smoking CessationAlcohol-Related Disorders

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
David Kalman, PhD
Organization
University of Massachusetts Medical School
kalmand@comcast.net
9785782371

Study Officials

  • David Kalman, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigatgor

Study Record Dates

First Submitted

March 17, 2006

First Posted

March 20, 2006

Study Start

April 1, 2005

Primary Completion

February 1, 2010

Study Completion

February 1, 2011

Last Updated

May 15, 2017

Results First Posted

May 15, 2017

Record last verified: 2017-05

Locations

US(1)