AlcoholismPhase 4DEFINE IINCT00817089

Understanding Treatment Response With Naltrexone Among White Alcoholics

A Phase 4 study testing Naltrexone in people with Alcoholism, run by University of Pennsylvania 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

Search all trials

Trial summary

This is a study involving treatment for alcohol dependence among males of European or Asian decent. The ultimate aim of this line of investigation is to further establish a genetic link between alcohol dependence and treatment by defining an endophenotype associated with treatment response. Read more about this study

Who is it for?: Ages 21 to 64 years, men only
Conditions the study is for: Alcoholism
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: 24 participants
Where: 1 siteUnited States
Study dates: Dec 2007to Jun 2010
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 to 64 years
Men only
No healthy volunteers
Adult

Who may be able to join

Males 21 years of age or older of European or Asian decent.
Has a current DSM IV diagnosis of alcohol dependence as determined by the Structural Clinical Interview for DSM IV (SCID-IV Mini).
Drank an average of 21 drinks/week in the 60 days prior to treatment and had at least 2 occasions of heavy drinking (5 or more drinks on a given day for men), as measured by the Timeline Followback (TLFB).
Has adequate vision, hearing, and ability to communicate to allow study participation.
Successfully completes detoxification as manifested by at least 48 consecutive hours of no self-reported alcohol use immediately prior to admission to the inpatient unit.
Has signed a witnessed informed consent
Scores below an 8 on the Clinical Inventory of Withdrawal for Alcohol (CIWA) prior to starting naltrexone/placebo; and 8) Can speak, print, and understand English.

Who cannot join

Meets DSM-IV criteria for dependence on any substance other than alcohol or nicotine in the last 6 months.
Tests positive on the urine drug screen for opioids, cocaine, or amphetamine at the screening visit (only 1 repeat test permitted).
Meets 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
Has taken any psychotropic medications (including disulfiram) regularly within the last seven days prior to randomization (14 days for fluoxetine) or needs immediate treatment with a psychotropic medication (with the exception of detoxification medications or benadryl used sparingly for sleep)
Over age 64 and has evidence of severe cognitive impairment as evidenced by a Mini-mental status exam (MMSE) score <24

Show all 11Show fewer

Has suicidal or homicidal ideation necessitating inpatient hospitalization
Has been abstinent more than 14 days prior to Phase 1
Is of African Descent
Meets current DSM-IV criteria for for major depression (non-substance induced), PTSD, or panic disorder.
Has significant hematological, pulmonary, endocrine, cardiovascular, renal, or gastrointestinal disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Defining an Endopheneotype for Alcohol Treatment With Naltrexone

Read the detailed description

Despite the well-established efficacy of naltrexone, there are significant variations in individual responses to naltrexone. A critical question remains: under what circumstances and for which patients will naltrexone be most beneficial? Recent work at our center provides evidence that the mu-opioid receptor (OPRM1) gene polymorphism A118G (Asn40Asp) imparts a significant change in treatment response. We have shown that patients with Asn40 variant (absence of heavy drinking -73.9% v/s 49% response). To further consolidate our knowledge, we wish to test the relationship between A118G polymorphism and the subjective/objective measures to alcohol among alcoholics treated with naltrexone. This work is focused on subjects of European or Asian decent as the A118G polymorphism occurs in less than 1% of those of African decent.

Up to 40 subjects will be recruited. The subjects were admitted to the UPenn Translational Research Center and receive two alcohol challenge sessions after pretreatment with naltrexone or placebo.

Conditions: Alcoholism
Being tested: Placebo Oral Tablet, Naltrexone
Medical subject headings: Alcoholism

What participants receive

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

Placebo Oral TabletDrug
Also called Placebo
Placebo pill
NaltrexoneDrug
50 mg of naltrexone prior to challenge session

Study groups in NCT00817089
Study group	Role	What they receive
Group 1 Asn40 Placebo Placebo	Placebo comparator	Each alcohol session preceded by pretreatment with placebo oral tablet Receives: Drug: Placebo Oral Tablet
Group 2 Asn40 Placebo Naltrexone	Active comparator	The first alcohol session preceded by pretreatment with placebo oral tablet. The second alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose. Receives: Drug: Placebo Oral Tablet; Drug: Naltrexone
Group 3 Asp40 Placebo Placebo	Placebo comparator	Each alcohol session preceded by pretreatment with placebo oral tablet Receives: Drug: Placebo Oral Tablet
Group 4 Asp40 Placebo Naltrexone	Active comparator	The first alcohol session preceded by pretreatment with placebo oral tablet. The second alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose. Receives: Drug: Placebo Oral Tablet; Drug: Naltrexone

What is being measured

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

Biphasic Alcohol Effects Scale:Total Mood
Change from baseline to peak cortisol response, during the 2nd alcohol challenge session, subjective response as measured by Biphasic Alcohol Effects Scale: Total Mood.
Biphasic Alcohol Effects Scale: Total Mood: minimum = 0, maximum = 106, higher scores indicate better outcomes.
Measured: during 2nd alcohol challenge session

Secondary outcomes (1)

Adrenocorticotropic Hormone (ACTH) Levels
Change from baseline to peak cortisol response during the 2nd alcohol challenge session, objective response as measured by Adrenocorticotropic hormone (ACTH).
Measured: during 2nd alcohol challenge session

Timeline

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

Dec 2007Jun 2010

First posted6 Jan 2009 (estimated)
Study startDec 2007
Primary completionApr 2010
Study completionJun 2010

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 AlcoholismStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Groups 1 and 3 get placebo in session 1 and placebo in session 2, Groups 2 and 4 get placebo in session 1 and naltrexone in session 2
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00817089
Sponsor's protocol ID: 806019
Acronym: DEFINE II
Status last verified: Oct 2019
First submitted: 5 Jan 2009
Last updated: 21 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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

Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder

All Alcoholism trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Defining an Endopheneotype for Alcohol Treatment With Naltrexone
ClinicalTrials.gov ID: NCT00817089
Acronym / sponsor ID: DEFINE II / 806019
Conditions: Alcoholism
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: Dec 2007
Primary completion: Apr 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 6 Jan 2009 (estimated)
Results: Posted 21 Nov 2019

Clinical summary

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

Detailed description

Up to 40 subjects will be recruited. The subjects were admitted to the UPenn Translational Research Center and receive two alcohol challenge sessions after pretreatment with naltrexone or placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Groups 1 and 3 get placebo in session 1 and placebo in session 2, Groups 2 and 4 get placebo in session 1 and naltrexone in session 2

Arm	Type	Receives
Group 1 Asn40 Placebo Placebo	Placebo comparator	Drug: Placebo Oral TabletEach alcohol session preceded by pretreatment with placebo oral tablet
Group 2 Asn40 Placebo Naltrexone	Active comparator	Drug: Placebo Oral Tablet, Drug: NaltrexoneThe first alcohol session preceded by pretreatment with placebo oral tablet. The second alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose.
Group 3 Asp40 Placebo Placebo	Placebo comparator	Drug: Placebo Oral TabletEach alcohol session preceded by pretreatment with placebo oral tablet
Group 4 Asp40 Placebo Naltrexone	Active comparator	Drug: Placebo Oral Tablet, Drug: NaltrexoneThe first alcohol session preceded by pretreatment with placebo oral tablet. The second alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose.

Who may qualify

Ages: 21 to 64 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Males 21 years of age or older of European or Asian decent.
Has a current DSM IV diagnosis of alcohol dependence as determined by the Structural Clinical Interview for DSM IV (SCID-IV Mini).
Drank an average of 21 drinks/week in the 60 days prior to treatment and had at least 2 occasions of heavy drinking (5 or more drinks on a given day for men), as measured by the Timeline Followback (TLFB).
Has adequate vision, hearing, and ability to communicate to allow study participation.
Successfully completes detoxification as manifested by at least 48 consecutive hours of no self-reported alcohol use immediately prior to admission to the inpatient unit.

Key exclusion criteria (11 listed)

Meets DSM-IV criteria for dependence on any substance other than alcohol or nicotine in the last 6 months.
Tests positive on the urine drug screen for opioids, cocaine, or amphetamine at the screening visit (only 1 repeat test permitted).
Meets 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
Has taken any psychotropic medications (including disulfiram) regularly within the last seven days prior to randomization (14 days for fluoxetine) or needs immediate treatment with a psychotropic medication (with the exception of detoxification medications or benadryl used sparingly for sleep)

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
Placebo Oral TabletAlso: PlaceboPlacebo pill	Drug	Group 1 Asn40 Placebo Placebo, Group 2 Asn40 Placebo Naltrexone, Group 3 Asp40 Placebo Placebo, Group 4 Asp40 Placebo Naltrexone
Naltrexone50 mg of naltrexone prior to challenge session	Drug	Group 2 Asn40 Placebo Naltrexone, Group 4 Asp40 Placebo Naltrexone

Primary outcome

Biphasic Alcohol Effects Scale:Total Mood
Time frame: during 2nd alcohol challenge session
Change from baseline to peak cortisol response, during the 2nd alcohol challenge session, subjective response as measured by Biphasic Alcohol Effects Scale: Total Mood. Biphasic Alcohol Effects Scale: Total Mood: minimum = 0, maximum = 106, higher scores indicate better outcomes.

1 secondary outcome

Adrenocorticotropic Hormone (ACTH) Levels
Time frame: during 2nd alcohol challenge session

Results and safety

Results posted to the registry on 21 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Asn40 Placebo Placebo	6	6
Group 2: Asn40 Placebo Naltrexone	8	8
Group 3: Asp40 Placebo Placebo	4	4
Group 4: Asp40 Placebo Naltrexone	6	5

Primary outcome: Biphasic Alcohol Effects Scale:Total Mood

Time frame: during 2nd alcohol challenge session. Mean (Standard Deviation). Unit: units on a scale

Measure	Group 1: Asn40 Placebo Placebo n = 6	Group 2: Asn40 Placebo Naltrexone n = 7	Group 3: Asp40 Placebo Placebo n = 4	Group 4: Asp40 Placebo Naltrexone n = 5
Value	6.94 (9.53)	3.57 (18.46)	6.50 (4.04)	3.20 (8.11)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 36 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Asn40 Placebo Placebo	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Group 2: Asn40 Placebo Naltrexone	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Group 3: Asp40 Placebo Placebo	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Group 4: Asp40 Placebo Naltrexone	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Alcoholism

Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder

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, M.D. 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 in people with Alcoholism, 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 7 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 21 Nov 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 Nov 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:Total Mood (time frame: during 2nd alcohol challenge session). 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 NCT00817089.

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 Nov 2019.