Hazardous DrinkingPhase 2NCT00938886
Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment
A Phase 2 study testing Naltrexone in people with Hazardous Drinking and Cigarette Smoking, run by Brown University at 1 site in United States.
Trial summary
To test whether naltrexone compared to placebo can reduce heavy drinking and improve smoking cessation outcomes in heavy drinkers seeking smoking cessation treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hazardous Drinking, Cigarette Smoking
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.) be at least 18 years of age, 2.) drink heavily at least once per month on average (≥4 drinks per occasion for women; ≥5 drinks for men), 3.) have smoked cigarettes regularly for at least one year, 4.) currently smoke at least 5 cigarettes a day, 5.) currently be using no other tobacco products or nicotine replacement therapy
Who cannot join
- 1.) meet criteria for current substance dependence (excluding nicotine and alcohol); 2.) report opiate use in the past month, have a drug screen positive for opiates, or require opiate containing medications for pain management; 3.) meet criteria for a current major depressive or manic episode; 4.) are currently psychotic or suicidal; 5.) have an unstable or serious medical condition that would preclude use of the nicotine patch or naltrexone (e.g., unstable angina pectoris, severe arrhythmia, recent congestive heart failure); 6.) have aspartate aminotransferase or alanine aminotransferase levels of more than 3 times the reference range or elevated bilirubin levels; or 7.) are currently pregnant or lactating, intend to become pregnant, or are not using a reliable means of birth control.
Trial locations and contacts
1 site in 1 country.
About this study
To test whether naltrexone compared to placebo can reduce heavy drinking and improve smoking cessation outcomes in heavy drinkers seeking smoking cessation treatment.
Read the detailed description
A substantial portion of individuals seeking behavioral and pharmacological treatment for smoking cessation drink excessively with many reporting significant alcohol problems. Although these at-risk and problem drinkers are unlikely to choose abstinence from alcohol as a goal, many make substantial reductions in their drinking during and after their quit smoking attempt. Thus, the context of smoking cessation treatment offers a unique and valuable opportunity in which to apply brief interventions and pharmacotherapy to catalyze change in excessive drinking in a population with markedly elevated risk for negative health outcomes. In our recent randomized clinical trial, standard smoking cessation treatment that incorporated a brief alcohol intervention showed promise in reducing drinking as well as in improving smoking cessation outcomes among heavy drinkers. However, these effects were relatively modest, especially among the heaviest drinkers, indicating that further study is warranted of methods to address heavy drinking in smoking cessation including the use of relevant pharmacotherapy. Naltrexone, in particular, shows promise for this purpose.
The overall aim of this project is to test the efficacy of naltrexone as a pharmacotherapy for excessive drinking when delivered to at-risk or problem drinkers who are seeking smoking cessation treatment. The proposed clinical trial uses a between-subjects design in which 300 at-risk or problem drinkers seeking treatment for smoking cessation will be randomly assigned to receive either daily 50 mg naltrexone or placebo. Medication will be initiated 2 weeks prior to participants' smoking quit date and continue for 10 weeks. All participants also will receive transdermal nicotine patch and a counseling and medication management intervention that provides advice for smoking cessation, advice regarding the effects of heavy drinking on both smoking cessation and health, and monitoring and encouragement of compliance with medications. Drinking and smoking outcomes will be assessed at 2, 8, 16, and 26 weeks after participants' smoking quit date. The primary aim of the study is to test the hypothesis that naltrexone will result in greater reductions in heavy drinking relative to placebo. The secondary aim will test whether naltrexone results in superior smoking outcomes relative to placebo, and tertiary aims will examine interrelationships among motivation for changing drinking, compliance with naltrexone, and drinking and smoking outcomes.
This study represents the first of its kind to provide naltrexone in conjunction with an opportunistic brief alcohol intervention for at-risk and problem drinkers not seeking alcohol treatment. Testing the potential benefits of naltrexone among at-risk and problem drinkers who smoke is of very high significance for public health efforts to reduce the markedly elevated rates of morbidity and mortality observed in this large, yet relatively understudied group.
- Conditions
- Hazardous Drinking, Cigarette Smoking
- Being tested
- Naltrexone, Placebo
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Daily 50 mg naltrexone
PlaceboDrug
Matched naltrexone placebo
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Experimental | 50 mg daily naltrexone for 10 weeks Receives: Drug: Naltrexone |
| Placebo | Placebo comparator | Daily matched placebo pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Heavy Drinking Days
Defined for women as percent of days drinking 4 or more drinks in a day. For men, percent of days drinking 5 or more drinks in a day
Measured: Across the 6 months following smoking quit date
Secondary outcomes (1)
7-day Point Prevalence Smoking Abstinence
Self-report abstinence from smoking over the past 7 days biochemically confirmed with carbon monoxide and saliva cotinine.
Measured: 26 weeks after target quit smoking date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2015
- Study completionDec 2015
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 Hazardous DrinkingStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher W. Kahler, Brown University
- Investigators
- Christopher W. Kahler, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938886
- Sponsor's protocol ID
- NIAAA-17181-1
- Status last verified
- Apr 2017
- First submitted
- 13 Jul 2009
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment
- ClinicalTrials.gov ID
- NCT00938886
- Acronym / sponsor ID
- NIAAA-17181-1
- Conditions
- Hazardous Drinking, Cigarette Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test whether naltrexone compared to placebo can reduce heavy drinking and improve smoking cessation outcomes in heavy drinkers seeking smoking cessation treatment.
Detailed description
A substantial portion of individuals seeking behavioral and pharmacological treatment for smoking cessation drink excessively with many reporting significant alcohol problems. Although these at-risk and problem drinkers are unlikely to choose abstinence from alcohol as a goal, many make substantial reductions in their drinking during and after their quit smoking attempt. Thus, the context of smoking cessation treatment offers a unique and valuable opportunity in which to apply brief interventions and pharmacotherapy to catalyze change in excessive drinking in a population with markedly elevated risk for negative health outcomes. In our recent randomized clinical trial, standard smoking cessation treatment that incorporated a brief alcohol intervention showed promise in reducing drinking as well as in improving smoking cessation outcomes among heavy drinkers. However, these effects were relatively modest, especially among the heaviest drinkers, indicating that further study is warranted of methods to address heavy drinking in smoking cessation including the use of relevant pharmacotherapy. Naltrexone, in particular, shows promise for this purpose.
The overall aim of this project is to test the efficacy of naltrexone as a pharmacotherapy for excessive drinking when delivered to at-risk or problem drinkers who are seeking smoking cessation treatment. The proposed clinical trial uses a between-subjects design in which 300 at-risk or problem drinkers seeking treatment for smoking cessation will be randomly assigned to receive either daily 50 mg naltrexone or placebo. Medication will be initiated 2 weeks prior to participants' smoking quit date and continue for 10 weeks. All participants also will receive transdermal nicotine patch and a counseling and medication management intervention that provides advice for smoking cessation, advice regarding the effects of heavy drinking on both smoking cessation and health, and monitoring and encouragement of compliance with medications. Drinking and smoking outcomes will be assessed at 2, 8, 16, and 26 weeks after participants' smoking quit date. The primary aim of the study is to test the hypothesis that naltrexone will result in greater reductions in heavy drinking relative to placebo. The secondary aim will test whether naltrexone results in superior smoking outcomes relative to placebo, and tertiary aims will examine interrelationships among motivation for changing drinking, compliance with naltrexone, and drinking and smoking outcomes.
This study represents the first of its kind to provide naltrexone in conjunction with an opportunistic brief alcohol intervention for at-risk and problem drinkers not seeking alcohol treatment. Testing the potential benefits of naltrexone among at-risk and problem drinkers who smoke is of very high significance for public health efforts to reduce the markedly elevated rates of morbidity and mortality observed in this large, yet relatively understudied group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: Naltrexone50 mg daily naltrexone for 10 weeks |
| Placebo | Placebo comparator | Drug: PlaceboDaily matched placebo pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.) be at least 18 years of age, 2.) drink heavily at least once per month on average (≥4 drinks per occasion for women; ≥5 drinks for men), 3.) have smoked cigarettes regularly for at least one year, 4.) currently smoke at least 5 cigarettes a day, 5.) currently be using no other tobacco products or nicotine replacement therapy
Key exclusion criteria (1 listed)
- 1.) meet criteria for current substance dependence (excluding nicotine and alcohol); 2.) report opiate use in the past month, have a drug screen positive for opiates, or require opiate containing medications for pain management; 3.) meet criteria for a current major depressive or manic episode; 4.) are currently psychotic or suicidal; 5.) have an unstable or serious medical condition that would preclude use of the nicotine patch or naltrexone (e.g., unstable angina pectoris, severe arrhythmia, recent congestive heart failure); 6.) have aspartate aminotransferase or alanine aminotransferase levels of more than 3 times the reference range or elevated bilirubin levels; or 7.) are currently pregnant or lactating, intend to become pregnant, or are not using a reliable means of birth control.
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 |
|---|---|---|
| NaltrexoneDaily 50 mg naltrexone | Drug | Naltrexone |
| PlaceboMatched naltrexone placebo | Drug | Placebo |
Primary outcome
Percent Heavy Drinking Days
Time frame: Across the 6 months following smoking quit date
Defined for women as percent of days drinking 4 or more drinks in a day. For men, percent of days drinking 5 or more drinks in a day
1 secondary outcome
7-day Point Prevalence Smoking Abstinence
Time frame: 26 weeks after target quit smoking date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Christopher W. Kahler, Ph.D. principal investigator
Brown 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 in people with Hazardous Drinking and Cigarette Smoking, run by Brown 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 1 inclusion and 1 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 15 May 2017. 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 15 May 2017). 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?
Percent Heavy Drinking Days (time frame: Across the 6 months following smoking quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2017.