HealthyPhase 4DEFINENCT00256451
Endophenotype for Alcohol Misuse in Healthy Minority Populations
A Phase 4 study testing Naltrexone and alcohol in people with Healthy, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approved for the… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Naltrexone and alcohol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to May 2008
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female and 21 years of age or older
- Drinks less than an average of 21 drinks/week with no more than 2 binge episodes per week
- Of African descent by self report
Who cannot join
- Meets DSM-IV criteria for lifetime dependence on any substance other than nicotine
- Subjects who test positive on the urine drug screen for opioids, cocaine, marijuana, or amphetamine at the screening visit
- Subjects who meet current or lifetime DSM-IV criteria for bipolar affective disorder, schizophrenia, or any psychotic disorder
- The presence of unstable or serious medical illness; including history of stroke, seizure disorder, severe liver disease (AST or ALT > 5X normal at the time of randomization), or unstable cardiac disease
- Needs treatment with any psychotropic medication (antidepressant, antipsychotic, benzodiazepine, or mood stabilizing medication)
- Pre-menopausal female subjects who are pregnant, nursing, or not using a reliable method of contraception
- Insulin-dependent diabetes
- Any medical or psychological condition that could jeopardize the subject's safe participation in the trial as determined by the PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Defining an Endophenotype for Alcohol Misuse: A Focus On Minority Populations
The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approved for the treatment of alcoholism. The investigators are conducting this study on those of African descent because there is almost no research focused on this group and the association with genetics. The investigators seek to enroll 40 people in the study. Participation will consist of 4 different alcohol challenge sessions in a cross over design. Each session will be separated by at least 10 days. In total, there will be four challenge sessions.
Read the detailed description
We propose to test the degree to which specific genetic markers alter the relationship between subjective and objective measures of response to alcohol ingestion among non-alcohol dependent adults of African descent in a laboratory environment. To meet this aim, non-alcohol dependent adults of African descent will be recruited for participation to meet the N-goal of 40 trial completers. After consenting, genotyping, and completing the baseline assessment, they will participate in four separate alcohol challenge sessions separated by at least 10 days. During each of the sessions, subjects will be administered alcohol or sham drinking challenge sessions and pretreatment with either naltrexone (50 mg/day) or placebo in a double-blind fashion. The order of the four sessions will be randomly assigned. During each session, physiological and subjective response will be measured. We will select subjects to assure equal number of participants with at least one copy of the Val6 allele compared to those homozygous for the Ala6 allele.
- Conditions
- Healthy
- Being tested
- Naltrexone, placebo, alcohol, Sham alcohol
- Keywords
- Naltrexone, Alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called ReVia
50 mg/day for two days prior to the alcohol challenge session
placeboDrug
placebo pills
alcoholOther
190 proof alcohol prepared to 11% volume mixed with fruit juice.
Sham alcoholOther
non-alcoholic placebo alcohol
| Study group | Role | What they receive |
|---|---|---|
| ALC and NAL | Experimental | alcohol and active naltrexone Receives: Drug: Naltrexone; Other: alcohol |
| Sham ALC and NAL | Active comparator | "sham" alcohol and active naltrexone Receives: Drug: Naltrexone; Other: Sham alcohol |
| placebo pill and ALC | Placebo comparator | placebo naltrexone and alcohol Receives: Drug: placebo; Other: alcohol |
| placebo pill and Sham ALC | Placebo comparator | placebo naltrexone and placebo (non-alcoholic) alcohol Receives: Drug: placebo; Other: Sham alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biphasic Alcohol Effects Scale - Stimulation
Change from baseline to peak for the feeling of stimulation after alcohol ingestion
Biphasic Alcohol Effects Scale - Stimulation: sum of 7 items each rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, higher scores=worse outcome.
Measured: During challenge sessions
Profile of Mood States - Vigor
Change from baseline to peak for the amount of Vigor experienced after alcohol ingestion
Profile of Mood States - Vigor: sum of 6 items each rated on 5 point Likert scale (0: not at all, 4: extremely). Minimum=0, maximum=20, higher scores = better outcome
Measured: during the challenge session
Subjective High From Alcohol Scale
Change from baseline to peak for the self reported feeling of being high after drinking
Subjective High from Alcohol Scale: sum of 15 items rated on a 8 point Likert scale (0-7). Minimum=0, maximum=105, higher scores=worse outcomes
Measured: during the alcohol ingestion
Secondary outcomes (2)
Biphasic Alcohol Effects Scale - Sedation
Change from baseline to peak of the amount of sedation post ingestion of alcohol
Biphasic alcohol effects scale - Sedation: sum of 7 items rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, lower scores=worse outcomes
Measured: During the challenge session
Profile of Mood States - Fatigue Scale
Change from baseline to peak of the degree of fatigue experienced after alcohol ingestion
Profile of Mood States - Fatigue scale: sum of 5 items rated on 5-point Likert scale (0=not at all, 4=extremely). Minimum=0, maximum=20, higher score=worse outcome
Measured: During the challenge session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionMay 2008
- Study completionMay 2008
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 HealthyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Oslin, University of Pennsylvania
- Investigators
- David Oslin, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256451
- Sponsor's protocol ID
- 803866
- Acronym
- DEFINE
- Status last verified
- Aug 2019
- First submitted
- 17 Nov 2005
- Last updated
- 21 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining an Endophenotype for Alcohol Misuse: A Focus On Minority Populations
- ClinicalTrials.gov ID
- NCT00256451
- Acronym / sponsor ID
- DEFINE / 803866
- Conditions
- Healthy
- Keywords
- Naltrexone, Alcohol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Posted 21 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approved for the treatment of alcoholism. The investigators are conducting this study on those of African descent because there is almost no research focused on this group and the association with genetics. The investigators seek to enroll 40 people in the study. Participation will consist of 4 different alcohol challenge sessions in a cross over design. Each session will be separated by at least 10 days. In total, there will be four challenge sessions.
Detailed description
We propose to test the degree to which specific genetic markers alter the relationship between subjective and objective measures of response to alcohol ingestion among non-alcohol dependent adults of African descent in a laboratory environment. To meet this aim, non-alcohol dependent adults of African descent will be recruited for participation to meet the N-goal of 40 trial completers. After consenting, genotyping, and completing the baseline assessment, they will participate in four separate alcohol challenge sessions separated by at least 10 days. During each of the sessions, subjects will be administered alcohol or sham drinking challenge sessions and pretreatment with either naltrexone (50 mg/day) or placebo in a double-blind fashion. The order of the four sessions will be randomly assigned. During each session, physiological and subjective response will be measured. We will select subjects to assure equal number of participants with at least one copy of the Val6 allele compared to those homozygous for the Ala6 allele.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALC and NAL | Experimental | Drug: Naltrexone, Other: alcoholalcohol and active naltrexone |
| Sham ALC and NAL | Active comparator | Drug: Naltrexone, Other: Sham alcohol"sham" alcohol and active naltrexone |
| placebo pill and ALC | Placebo comparator | Drug: placebo, Other: alcoholplacebo naltrexone and alcohol |
| placebo pill and Sham ALC | Placebo comparator | Drug: placebo, Other: Sham alcoholplacebo naltrexone and placebo (non-alcoholic) alcohol |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female and 21 years of age or older
- Drinks less than an average of 21 drinks/week with no more than 2 binge episodes per week
- Of African descent by self report
Key exclusion criteria (8 listed)
- Meets DSM-IV criteria for lifetime dependence on any substance other than nicotine
- Subjects who test positive on the urine drug screen for opioids, cocaine, marijuana, or amphetamine at the screening visit
- Subjects who meet current or lifetime DSM-IV criteria for bipolar affective disorder, schizophrenia, or any psychotic disorder
- The presence of unstable or serious medical illness; including history of stroke, seizure disorder, severe liver disease (AST or ALT > 5X normal at the time of randomization), or unstable cardiac disease
- Needs treatment with any psychotropic medication (antidepressant, antipsychotic, benzodiazepine, or mood stabilizing medication)
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 |
|---|---|---|
| NaltrexoneAlso: ReVia50 mg/day for two days prior to the alcohol challenge session | Drug | ALC and NAL, Sham ALC and NAL |
| placeboplacebo pills | Drug | placebo pill and ALC, placebo pill and Sham ALC |
| alcohol190 proof alcohol prepared to 11% volume mixed with fruit juice. | Other | ALC and NAL, placebo pill and ALC |
| Sham alcoholnon-alcoholic placebo alcohol | Other | Sham ALC and NAL, placebo pill and Sham ALC |
Primary outcome
Biphasic Alcohol Effects Scale - Stimulation
Time frame: During challenge sessions
Change from baseline to peak for the feeling of stimulation after alcohol ingestion Biphasic Alcohol Effects Scale - Stimulation: sum of 7 items each rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, higher scores=worse outcome.
Profile of Mood States - Vigor
Time frame: during the challenge session
Change from baseline to peak for the amount of Vigor experienced after alcohol ingestion Profile of Mood States - Vigor: sum of 6 items each rated on 5 point Likert scale (0: not at all, 4: extremely). Minimum=0, maximum=20, higher scores = better outcome
Subjective High From Alcohol Scale
Time frame: during the alcohol ingestion
Change from baseline to peak for the self reported feeling of being high after drinking Subjective High from Alcohol Scale: sum of 15 items rated on a 8 point Likert scale (0-7). Minimum=0, maximum=105, higher scores=worse outcomes
2 secondary outcomes
Biphasic Alcohol Effects Scale - Sedation
Time frame: During the challenge session
Profile of Mood States - Fatigue Scale
Time frame: During the challenge session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David Oslin, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone and alcohol in people with Healthy, run by University of Pennsylvania 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 8 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 21 Aug 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 21 Aug 2019). 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?
Biphasic Alcohol Effects Scale - Stimulation (time frame: During challenge sessions). The study lists 3 primary outcomes in all. 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 21 Aug 2019.