Understanding Treatment Response With Naltrexone Among White Alcoholics

NCT00817089 | Completed Phase 4 Results DMC

• 1 other identifier: 806019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. The study consists of two inpatient alcohol challenge sessions with treatment using random assignment to either naltrexone or placebo.

Conditions

Alcoholism

Outcome Measures

Primary Outcomes (1)

• 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.

  during 2nd alcohol challenge session

Secondary Outcomes (1)

• Adrenocorticotropic Hormone (ACTH) Levels

  during 2nd alcohol challenge session

Study Arms (4)

Group 1 Asn40 Placebo Placebo

PLACEBO COMPARATOR

Each alcohol session preceded by pretreatment with placebo oral tablet

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.

Drug: Placebo Oral Tablet; Drug: Naltrexone

Group 3 Asp40 Placebo Placebo

PLACEBO COMPARATOR

Each alcohol session preceded by pretreatment with placebo oral tablet

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.

Drug: Placebo Oral Tablet; Drug: Naltrexone

Interventions

Placebo Oral Tablet DRUG

Placebo pill

Also known as: Placebo

Group 1 Asn40 Placebo Placebo; Group 2 Asn40 Placebo Naltrexone; Group 3 Asp40 Placebo Placebo; Group 4 Asp40 Placebo Naltrexone

Naltrexone DRUG

50 mg of naltrexone prior to challenge session

Group 2 Asn40 Placebo Naltrexone; Group 4 Asp40 Placebo Naltrexone

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: David Oslin
• Organization: UPENN

oslin@upenn.edu

215 823 5894

Study Officials

• David Oslin, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: December 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 21, 2019
• Results First Posted: November 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)