Tobacco Use CessationPhase 4NCT00132821
Impact of Smoking Cessation on Sleep - 5
A Phase 4 study testing Bupropion and Transdermal Nicotine Patch in people with Tobacco Use Cessation and Sleep Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation, Sleep Disorders
- What is being tested?
- Bupropion and Transdermal Nicotine Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Smoking Cessation on Sleep
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.
Read the 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, commonly causes sleep disturbances as a medication side effect. In addition, a number of NRTs also cause sleep disturbances. This study will aim to characterize the effect of smoking cessation and smoking cessation treatments on sleep by measuring central and autonomic nervous system arousal. The study will also evaluate the impact of smoking cessation treatments on daytime sleepiness and mood as well as their effect on smoking relapse.
Participants will be randomly assigned to one of four groups. Participants will receive either bupropion (150 mg for 3 days and 300 mg for 60 days) or placebo, starting one week prior to smoking quit day. They will then receive either active NRT (21 mg for 6 weeks, 14 mg for 1 week, and 7 mg for 1 week) or placebo, starting on quit day. Participants will be studied for up to 5 nights in a sleep lab. Sleep studies will include polysomnography measurements, including electrooculography of both eyes, activity of mentalis muscle and both anterior tibialis muscles, EEG, ECG, oxygen saturation, airflow, and respiratory efforts. Sleep studies will occur on the 2 nights prior to quit day, the quit night, and the 2 nights after quitting. Each sleep study will be followed by daytime measures. These will include a series of self-report instruments, sleepiness and performance measures, and physiological activity measures. Carbon monoxide levels will also be a daytime measurement and must fall below 10 ppm on the post quit days. All participants will receive bimonthly phone counseling for 12 months, starting on quit day. Participants will have follow-up evaluations at Months 3 and 12 in order to measure carbon monoxide levels and complete self-report instruments.
- Conditions
- Tobacco Use Cessation, Sleep Disorders
- Being tested
- Bupropion, Transdermal Nicotine Patch, Placebo Bupropion, Placebo transdermal nicotine patch
- Keywords
- Nicotine dependence, Sleep disorders, smoking cessation, Relapse
- Medical subject headings
- Tobacco Use Cessation, Sleep Wake Disorders, Tobacco Use Disorder, Smoking Cessation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Zyban
Days 1-3, 150 mg Bupropion in am; days 4-63, 300 mg Bupropion (150 mg in am and 150 mg in pm)
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
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)
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
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Bupropion Receives: Drug: Bupropion |
| B | Active comparator | Transdermal nicotine patch Receives: Drug: Transdermal Nicotine Patch |
| C | Placebo comparator | Not described Receives: Drug: Placebo Bupropion |
| D | Placebo comparator | Not described Receives: Drug: Placebo transdermal nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and post-cessation sleep measures by in-laboratory polysomnography
Measured: Up to 7 days post-cessation
Secondary outcomes (1)
Smoking cessation status confirmed by carbon monoxide levels
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gary Swan, Principal investigator, SRI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132821
- Sponsor's protocol ID
- NIDA-16427-5
- Other IDs
- R01-16427-5, DPMC
- Status last verified
- Jun 2009
- First submitted
- 18 Aug 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15801567
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Smoking Cessation on Sleep
- ClinicalTrials.gov ID
- NCT00132821
- Acronym / sponsor ID
- NIDA-16427-5
- Conditions
- Tobacco Use Cessation, Sleep Disorders
- Keywords
- Nicotine dependence, Sleep disorders, smoking cessation, Relapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Aug 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, commonly causes sleep disturbances as a medication side effect. In addition, a number of NRTs also cause sleep disturbances. This study will aim to characterize the effect of smoking cessation and smoking cessation treatments on sleep by measuring central and autonomic nervous system arousal. The study will also evaluate the impact of smoking cessation treatments on daytime sleepiness and mood as well as their effect on smoking relapse.
Participants will be randomly assigned to one of four groups. Participants will receive either bupropion (150 mg for 3 days and 300 mg for 60 days) or placebo, starting one week prior to smoking quit day. They will then receive either active NRT (21 mg for 6 weeks, 14 mg for 1 week, and 7 mg for 1 week) or placebo, starting on quit day. Participants will be studied for up to 5 nights in a sleep lab. Sleep studies will include polysomnography measurements, including electrooculography of both eyes, activity of mentalis muscle and both anterior tibialis muscles, EEG, ECG, oxygen saturation, airflow, and respiratory efforts. Sleep studies will occur on the 2 nights prior to quit day, the quit night, and the 2 nights after quitting. Each sleep study will be followed by daytime measures. These will include a series of self-report instruments, sleepiness and performance measures, and physiological activity measures. Carbon monoxide levels will also be a daytime measurement and must fall below 10 ppm on the post quit days. All participants will receive bimonthly phone counseling for 12 months, starting on quit day. Participants will have follow-up evaluations at Months 3 and 12 in order to measure carbon monoxide levels and complete self-report instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: BupropionBupropion |
| B | Active comparator | Drug: Transdermal Nicotine PatchTransdermal nicotine patch |
| C | Placebo comparator | Drug: Placebo Bupropion |
| D | Placebo comparator | Drug: Placebo transdermal nicotine patch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionAlso: ZybanDays 1-3, 150 mg Bupropion in am; days 4-63, 300 mg Bupropion (150 mg in am and 150 mg in pm) | Drug | A |
| Transdermal Nicotine Patch21-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 | Drug | B |
| Placebo BupropionDays 1-3, 150 mg placebo Bupropion in am; days 4-63, 300 mg placebo Bupropion (150 mg in am and 150 mg in pm) | Drug | C |
| Placebo transdermal nicotine patch21-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 | Drug | D |
Primary outcome
Pre- and post-cessation sleep measures by in-laboratory polysomnography
Time frame: Up to 7 days post-cessation
1 secondary outcome
Smoking cessation status confirmed by carbon monoxide levels
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Background: PubMed 15801567Colrain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Swan principal investigator
SRI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupropion and Transdermal Nicotine Patch in people with Tobacco Use Cessation and Sleep Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre- and post-cessation sleep measures by in-laboratory polysomnography (time frame: Up to 7 days post-cessation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00132821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.