The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse

Smoking Clinical Trial

Official title:

The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773422
• Other study ID #: HIC0710003188
• Secondary ID: P50AA015632
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2008
• Last updated: March 22, 2018
• Start date: January 2008
• Est. completion date: November 2016

Study information

• Verified date: March 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine how medications thought to attenuate the effects of alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming drink, in non-treatment seeking alcohol-drinking daily smokers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

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).
• 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).
• placebo
placebo

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigation, Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency to Initiate Ad-lib Smoking Session	Time to smoking during the smoking delay task. Smoking delay task occurred on day 8 of the study. Range of time delay is 0 minutes to 50 minutes.	day 8
Secondary	Number of Cigarettes Smoked During the Ad-lib Period	Number of cigarettes smoked during the ad libitum phase of the smoking delay task. Task occurred on day 8 of the study.	day 8