NCT00773422

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 23, 2018

Completed
Last Updated

April 23, 2018

Status Verified

March 1, 2018

Enrollment Period

8.8 years

First QC Date

October 14, 2008

Results QC Date

February 21, 2018

Last Update Submit

March 22, 2018

Conditions

Smoking

Keywords

smoking lapse behaviorsmoking cessationvareniclinenaltrexonemedication effect on smoking lapse behavior

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Cigarettes Smoked During the Ad-lib Period

    day 8

Study Arms (3)

naltrexone + varenicline

EXPERIMENTAL

naltrexone (25mg) + varenicline (2mg)

Drug: naltrexoneDrug: varenicline

varenicline

EXPERIMENTAL

varenicline 2mg

Drug: varenicline

placebo

PLACEBO COMPARATOR

placebo control

Drug: placebo

Interventions

naltrexoneDRUG

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).

naltrexone + varenicline
vareniclineDRUG

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).

Also known as: Chantix
naltrexone + vareniclinevarenicline
placeboDRUG

placebo

placebo

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ages 21-55
  • ability to read and write in English
  • alcohol-drinking smokers

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Clinical Investigation, Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

SmokingSmoking Cessation

Interventions

NaltrexoneVarenicline

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingQuinoxalines

Results Point of Contact

Title
Sherry McKee, PhD
Organization
Yale School of Medicine
sherry.mckee@yale.edu
2037373529

Study Officials

  • Sherry A McKee, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

October 14, 2008

First Posted

October 16, 2008

Study Start

January 1, 2008

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 23, 2018

Results First Posted

April 23, 2018

Record last verified: 2018-03

Locations

US(1)