Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban

This study has been terminated.

( Study has been terminated due low recruitment of participant population. )

Study NCT00511134 Information provided by Yale University

First Received on August 1, 2007. Last Updated on December 18, 2009 History of Changes

Results First Received: September 28, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Insomnia Nicotine Dependence
Interventions:	Drug: Eszopiclone Drug: Bupropion

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the Greater New Haven area and surrounding communities through targeted television, radio, and newspaper ads, fliers, and referrals from clinicians. Recruitment occurred between July of 2007 and October of 2008. Approximately 900 phone screens and 12 in-person screens were completed during the course of the study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Major reasons for exclusion at phone screen were report of no sleep problems, use of illegal substances, psychiatric or medical exclusions, and low smoking. Major reasons for exclusion during the in-person screening process included withdrawal of informed consent, alcohol or illicit drug use, and low smoking.

Reporting Groups

	Description
Zyban + Lunesta	Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
Zyban + Placebo	Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)

Participant Flow: Overall Study

	Zyban + Lunesta	Zyban + Placebo
STARTED	1	3
COMPLETED	1	1
NOT COMPLETED	0	2
Withdrawal by Subject	0	2

Baseline Characteristics

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Reporting Groups

	Description
Zyban + Lunesta	Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
Zyban + Placebo	Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)

Baseline Measures

	Zyban + Lunesta	Zyban + Placebo	Total
Number of Participants [units: participants]	1	3	4
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	1	3	4
>=65 years	0	0	0
Gender [units: participants]
Female	0	1	1
Male	1	2	3
Region of Enrollment [units: participants]
United States	1	3	4

Outcome Measures

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1. Primary:

Level of Insomnia as Measured by the Insomnia Severity Index [ Time Frame: 6 weeks after target smoking quit date ]

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2. Secondary:

Smoking Abstinence as Measured by Self Reported Smoking and Confirmed by CO Level [ Time Frame: 6 weeks after target smoking quite date ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Andrea H. Weinberger, Ph.D.
Organization: Yale University
phone: 203-974-7598
e-mail: andrea.weinberger@yale.edu

No publications provided

Responsible Party:	Andrea Weinberger, Ph.D., Yale University School of Medicine
ClinicalTrials.gov Identifier:	NCT00511134 History of Changes
Other Study ID Numbers:	0609001866, ESRC099
Study First Received:	August 1, 2007
Results First Received:	September 28, 2009
Last Updated:	December 18, 2009
Health Authority:	United States: Institutional Review Board