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Understanding Treatment Response With Naltrexone Among White Alcoholics (DEFINE II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00817089
Recruitment Status : Completed
First Posted : January 6, 2009
Results First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
David Oslin, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Placebo Oral Tablet Drug: Naltrexone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Defining an Endopheneotype for Alcohol Treatment With Naltrexone
Study Start Date : December 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group 1 Asn40 Placebo Placebo
Each alcohol session preceded by pretreatment with placebo oral tablet
Drug: Placebo Oral Tablet
Placebo pill
Other Name: Placebo

Active Comparator: Group 2 Asn40 Placebo Naltrexone
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
Placebo pill
Other Name: Placebo

Drug: Naltrexone
50 mg of naltrexone prior to challenge session

Placebo Comparator: Group 3 Asp40 Placebo Placebo
Each alcohol session preceded by pretreatment with placebo oral tablet
Drug: Placebo Oral Tablet
Placebo pill
Other Name: Placebo

Active Comparator: Group 4 Asp40 Placebo Naltrexone
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
Placebo pill
Other Name: Placebo

Drug: Naltrexone
50 mg of naltrexone prior to challenge session




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Adrenocorticotropic Hormone (ACTH) Levels [ Time Frame: during 2nd alcohol challenge session ]
    Change from baseline to peak cortisol response during the 2nd alcohol challenge session, objective response as measured by Adrenocorticotropic hormone (ACTH).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males 21 years of age or older of European or Asian decent.
  2. Has a current DSM IV diagnosis of alcohol dependence as determined by the Structural Clinical Interview for DSM IV (SCID-IV Mini).
  3. 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).
  4. Has adequate vision, hearing, and ability to communicate to allow study participation.
  5. 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.
  6. Has signed a witnessed informed consent
  7. 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.

Exclusion Criteria:

  1. Meets DSM-IV criteria for dependence on any substance other than alcohol or nicotine in the last 6 months.
  2. Tests positive on the urine drug screen for opioids, cocaine, or amphetamine at the screening visit (only 1 repeat test permitted).
  3. Meets current or lifetime DSM-IV criteria for bipolar affective disorder, schizophrenia, or any psychotic disorder
  4. 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
  5. 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)
  6. Over age 64 and has evidence of severe cognitive impairment as evidenced by a Mini-mental status exam (MMSE) score <24
  7. Has suicidal or homicidal ideation necessitating inpatient hospitalization
  8. Has been abstinent more than 14 days prior to Phase 1
  9. Is of African Descent
  10. Meets current DSM-IV criteria for for major depression (non-substance induced), PTSD, or panic disorder.
  11. Has significant hematological, pulmonary, endocrine, cardiovascular, renal, or gastrointestinal disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817089


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: David Oslin, M.D. University of Pennsylvania
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Responsible Party: David Oslin, Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00817089    
Other Study ID Numbers: 806019
First Posted: January 6, 2009    Key Record Dates
Results First Posted: November 21, 2019
Last Update Posted: November 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents