NCT00132821

Brief Summary

Smoking is a major health problem with a direct link to elevated heart- and lung-related problems. Nicotine is highly addictive, which makes quitting difficult and relapse after quitting highly probable. Any type of sleep disturbance may make quitting even harder. The purpose of this study is to evaluate the effect of bupropion and nicotine replacement therapies (NRT) on sleep disturbances. In turn, this might show how such medications affect attempts at smoking cessation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_4

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

August 1, 2005

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

January 12, 2017

Status Verified

June 1, 2009

Enrollment Period

3.8 years

First QC Date

August 18, 2005

Last Update Submit

January 11, 2017

Conditions

Tobacco Use CessationSleep Disorders

Keywords

Nicotine dependenceSleep disorderssmoking cessationRelapse

Outcome Measures

Primary Outcomes (1)

  • Pre- and post-cessation sleep measures by in-laboratory polysomnography

    Up to 7 days post-cessation

Secondary Outcomes (1)

  • Smoking cessation status confirmed by carbon monoxide levels

    Up to 12 months

Study Arms (4)

A

ACTIVE COMPARATOR

Bupropion

Drug: Bupropion

B

ACTIVE COMPARATOR

Transdermal nicotine patch

Drug: Transdermal Nicotine Patch

C

PLACEBO COMPARATOR
Drug: Placebo Bupropion

D

PLACEBO COMPARATOR
Drug: Placebo transdermal nicotine patch

Interventions

BupropionDRUG

Days 1-3, 150 mg Bupropion in am; days 4-63, 300 mg Bupropion (150 mg in am and 150 mg in pm)

Also known as: Zyban
A
Transdermal Nicotine PatchDRUG

21-mg nicotine patch applied in AM for 6 weeks, starting on the morning of quit day; 14-mg patch applied in AM for 2 weeks; 7-mg patch applied in AM for 1 week

B
Placebo BupropionDRUG

Days 1-3, 150 mg placebo Bupropion in am; days 4-63, 300 mg placebo Bupropion (150 mg in am and 150 mg in pm)

C
Placebo transdermal nicotine patchDRUG

21-mg placebo nicotine patch applied in AM for 6 weeks, starting on the morning of quit day; 14-mg placebo patch applied in AM for 2 weeks; 7-mg placebo patch applied in AM for 1 week

D

Eligibility Criteria

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

You may qualify if:

  • Meets DSM-IV criteria for nicotine dependence
  • History of smoking at least 20 cigarettes each day for 2 years prior to enrollment
  • Expired carbon monoxide level of at least 10 ppm
  • Body mass index less than 30 kg/m2

You may not qualify if:

  • Meets DSM-IV criteria for dependence on substances other than nicotine and caffeine
  • Substance abuse within the year prior to enrollment
  • History of DSM-IV diagnosis of schizophrenia, bipolar disorder, obsessive compulsive disorder, or chronic depression
  • Current diagnosis of major depression
  • History of neurological illness or trauma (e.g., stroke, seizure disorder, febrile seizures, electroconvulsive therapy)
  • Family history of seizure disorder
  • History of head injury with loss of consciousness for longer than 1 hour
  • Currently diagnosed with a sleep disorder
  • Currently diagnosed with anorexia or bulimia
  • Severe or chronic cardiovascular, lung, kidney, or neurological disease
  • Uncontrolled hypertension or diabetes
  • Use of medications contraindicated with bupropion
  • High frequency alcohol use or binge drinking in the month prior to enrollment
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SRI International

Menlo Park, California, 94025, United States

Location

Related Publications (1)

  • Colrain IM, Trinder J, Swan GE. The impact of smoking cessation on objective and subjective markers of sleep: review, synthesis, and recommendations. Nicotine Tob Res. 2004 Dec;6(6):913-25. doi: 10.1080/14622200412331324938.

    PMID: 15801567BACKGROUND

MeSH Terms

Conditions

Tobacco Use CessationSleep Wake DisordersTobacco Use DisorderSmoking CessationRecurrence

Interventions

BupropionTobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSubstance-Related DisordersChemically-Induced DisordersDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsTherapeutics

Study Officials

  • Gary Swan

    SRI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 22, 2005

Study Start

August 1, 2005

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

January 12, 2017

Record last verified: 2009-06

Locations

US(1)