Status:
COMPLETED
Impact of Smoking Cessation on Sleep - 5
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Cessation
Sleep Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 probab...
Detailed Description
The majority of attempts to quit smoking end in failure due to unpleasant withdrawal symptoms. One such symptom is sleep disturbances. Bupropion, effective in assisting with smoking cessation, commonl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00132821
Start Date
August 1 2005
End Date
May 1 2009
Last Update
January 12 2017
Active Locations (1)
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1
SRI International
Menlo Park, California, United States, 94025