The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
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ClinicalTrials.gov Identifier: NCT00773422 |
Recruitment Status
:
Completed
First Posted
: October 16, 2008
Last Update Posted
: November 23, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking | Drug: naltrexone Drug: varenicline Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | November 2016 |
Actual Study Completion Date : | November 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: naltrexone + varenicline
naltrexone (25mg) + varenicline (2mg)
|
Drug: naltrexone
25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).
Drug: varenicline
2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
Other Name: Chantix
|
Experimental: varenicline
varenicline 2mg
|
Drug: varenicline
2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
Other Name: Chantix
|
Placebo Comparator: placebo
placebo control
|
Drug: placebo
placebo
|
- latency to initiate ad-lib smoking session [ Time Frame: in the laboratory session ]
- number of cigarettes smoked during the ad-lib period [ Time Frame: during the laboratory session ]

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ages 21-55
- ability to read and write in English
- alcohol-drinking smokers
Exclusion Criteria:
- any significant current medical conditions that would contraindicate smoking
- current DSM-IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse.
- positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- women who are pregnant or nursing
- suicidal, homicidal or evidence of current severe mental illness
- participants prescribed any psychotropic drug in the 30 days prior to study enrollment
- blood donation within the past 6 weeks
- individuals seeking treatment for smoking cessation or drinking or have attempted to quit smoking or drinking within the past 3 months
- specific exclusion for administration of naltrexone not specified above including chronic pain conditions necessitating opioid treatment, and evidence of significant hepatocellular injury as evidenced by SGOT or SGPT > 3x normal or elevated bilirubin
- known allergy to varenicline or taking H2blockers (e.g., Cimetidine)
- participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773422
United States, Connecticut | |
Yale Center for Clinical Investigation, Yale University | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Sherry A McKee, PhD | Yale University |
Responsible Party: | Sherry McKee, Associate Professor of Psychiatry, Yale University |
ClinicalTrials.gov Identifier: | NCT00773422 History of Changes |
Other Study ID Numbers: |
HIC0710003188 P50AA015632 ( U.S. NIH Grant/Contract ) |
First Posted: | October 16, 2008 Key Record Dates |
Last Update Posted: | November 23, 2016 |
Last Verified: | November 2016 |
Keywords provided by Sherry McKee, Yale University:
smoking lapse behavior smoking cessation varenicline naltrexone medication effect on smoking lapse behavior |
Additional relevant MeSH terms:
Naltrexone Varenicline Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |
Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |