Overview

Impact of Smoking Cessation on Sleep - 5

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Treatments:
Bupropion
Nicotine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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