SmokingPhase 2NCT00773422

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

A Phase 2 study testing naltrexone and varenicline in people with Smoking, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 21 to 55 years
Conditions the study is for: Smoking
What is being tested?: naltrexone and varenicline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Jan 2008to Nov 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale Center for Clinical Investigation, Yale University
New Haven, Connecticut, 06519

Other trials in United States

About this study

Conditions: Smoking
Being tested: naltrexone, varenicline, placebo
Keywords: smoking lapse behavior, smoking cessation, varenicline, naltrexone, medication effect on smoking lapse behavior
Medical subject headings: Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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).
vareniclineDrug
Also called Chantix
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).
placeboDrug
placebo

Study groups in NCT00773422
Study group	Role	What they receive
naltrexone + varenicline	Experimental	naltrexone (25mg) + varenicline (2mg) Receives: Drug: naltrexone; Drug: varenicline
varenicline	Experimental	varenicline 2mg Receives: Drug: varenicline
placebo	Placebo comparator	placebo control Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: day 8

Secondary outcomes (1)

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.
Measured: day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Nov 2016

First posted16 Oct 2008 (estimated)
Study startJan 2008
Primary completionNov 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SmokingStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00773422
Sponsor's protocol ID: HIC0710003188
Other IDs: P50AA015632
Status last verified: Mar 2018
First submitted: 14 Oct 2008
Last updated: 23 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
ClinicalTrials.gov ID: NCT00773422
Acronym / sponsor ID: HIC0710003188
Conditions: Smoking
Keywords: smoking lapse behavior, smoking cessation, varenicline, naltrexone, medication effect on smoking lapse behavior
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: Jan 2008
Primary completion: Nov 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 16 Oct 2008 (estimated)
Results: Posted 23 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
naltrexone + varenicline	Experimental	Drug: naltrexone, Drug: vareniclinenaltrexone (25mg) + varenicline (2mg)
varenicline	Experimental	Drug: vareniclinevarenicline 2mg
placebo	Placebo comparator	Drug: placeboplacebo control

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (11 listed)

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

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
naltrexone25 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	naltrexone + varenicline
vareniclineAlso: Chantix2mg/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).	Drug	naltrexone + varenicline, varenicline
placeboplacebo	Drug	placebo

Primary outcome

Latency to Initiate Ad-lib Smoking Session
Time frame: day 8
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.

1 secondary outcome

Number of Cigarettes Smoked During the Ad-lib Period
Time frame: day 8

Results and safety

Results posted to the registry on 23 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Naltrexone + Varenicline	11	11
Varenicline	9	9
Placebo	10	10

Primary outcome: Latency to Initiate Ad-lib Smoking Session

Time frame: day 8. Mean (Standard Error). Unit: minutes

Measure	Naltrexone + Varenicline n = 11	Varenicline n = 9	Placebo n = 10
Value	28.134 (5.328)	45.861 (6.238)	21.737 (6.043)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naltrexone + Varenicline	0 of 11 (0%)	3 of 11 (27.3%)	0 of 11
Varenicline	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
Placebo	0 of 10 (0%)	4 of 10 (40%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Enrolling by invitationObservational study
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Recruiting
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Not yet recruiting
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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.

Sherry A McKee, PhD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing naltrexone and varenicline in people with Smoking, run by Yale University 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 3 inclusion and 11 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 23 Apr 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Latency to Initiate Ad-lib Smoking Session (time frame: day 8). 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 NCT00773422.

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 23 Apr 2018.