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Trial record 51 of 80 for:    ASNS

Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism

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ClinicalTrials.gov Identifier: NCT00920829
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : June 4, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE June 11, 2009
First Posted Date  ICMJE June 15, 2009
Results First Submitted Date  ICMJE February 27, 2018
Results First Posted Date  ICMJE June 4, 2018
Last Update Posted Date July 10, 2018
Study Start Date  ICMJE June 2009
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
Percent Heavy Drinking Days by mu Opioid Receptor Gene [ Time Frame: Time Line Follow-Back drinking collected at each of 9 visits (weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16) ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
  • percent heavy drinking days by mu opitate receptor gene [ Time Frame: 16-week treatment period ]
  • brain activation by mu opiate receptor gene [ Time Frame: pre fMRI scan vs post fMRI ]
  • urine riboflavin by mu opiate receptor gene [ Time Frame: 16 week trial ]
  • adverse effects by mu opiate receptor gene [ Time Frame: 16 week trial ]
Change History Complete list of historical versions of study NCT00920829 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
  • clinical global outcome by mu opiate receptor gene [ Time Frame: during last 8 weeks of trial ]
  • drinks per drinking day based by mu opiate receptor gene [ Time Frame: 16 week trial ]
  • percent days abstinent by mu opiate receptor gene [ Time Frame: 16 week trial ]
  • craving as measured via OCDS by mu opiate receptor gene [ Time Frame: 16 week trial ]
  • %CDT and GGT levels measured as change from baseline by mu opiate receptor gene [ Time Frame: 16 week trial ]
  • psychological and general health function by mu opiate receptor gene [ Time Frame: 16 week trial ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism
Official Title  ICMJE Genetic and Brain Mechanisms of Naltrexone?s Treatment Efficacy for Alcoholism
Brief Summary The overarching aim of this trial is to evaluate naltrexone's efficacy in light of genetic variation and brain response to alcohol cues utilizing a neuroimaging paradigm. This trial has four specific aims. First, this trial will evaluate whether the presence of the OPRM1 Asp40 allele substitution is associated with improved treatment response to naltrexone in treatment-seeking alcoholics. Second, it will evaluate whether there is a difference in the naltrexone dampening of the alcohol cue-induced brain activation dependent on OPRM1 genotype. Third, it will explore whether alcohol cue-induced brain activation dampening by naltrexone might be a mediating factor in the treatment effects of naltrexone, the OPRM1 gene, or their interaction that might be observed in the first aim. Finally, this trial will evaluate the effect of medication compliance, or adverse effects, on the observed medication by genotype treatment response. A secondary aim will measure medication compliance and side effects based on OPRM1 genotype.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE
  • Drug: Naltrexone 50 Mg
    Naltrexone 25 or 50 mg per titration schedule
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • Active Comparator: A118G A/A with Naltrexone
    Individuals with the OPRM1 genotype Asn40 are given naltrexone 50 mg after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
    Intervention: Drug: Naltrexone 50 Mg
  • Placebo Comparator: A118G A/A with Placebo
    Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks
    Intervention: Drug: Placebo
  • Active Comparator: A118G Any G with Naltrexone
    Individuals with the OPRM1 genotype Any G (Asp) are given naltrexone 50 mg after 2 days of naltrexone 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
    Intervention: Drug: Naltrexone 50 Mg
  • Placebo Comparator: A118G Any G with Placebo
    Individuals with the OPRM1 genotype Any G (Asp) are given 50 mg naltrexone after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
    Intervention: Drug: Placebo
Publications * Schacht JP, Randall PK, Latham PK, Voronin KE, Book SW, Myrick H, Anton RF. Predictors of Naltrexone Response in a Randomized Trial: Reward-Related Brain Activation, OPRM1 Genotype, and Smoking Status. Neuropsychopharmacology. 2017 Dec;42(13):2640-2653. doi: 10.1038/npp.2017.74. Epub 2017 Apr 14. Erratum in: Neuropsychopharmacology. 2017 Dec;42(13):2654.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2018)
358
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2009)
160
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Age 18 70
  2. Subjects will meet criteria for primary alcohol dependence
  3. Consumes, on average, at least 5 standard drinks per day for men and 4 drinks per day for women in the 90 days pre-screening. Has at least 50% of days as heavy drinking days (as defined above).
  4. Able to maintain sobriety for four days (with or without the aid of alcohol detoxification medications) as determined by self report and breathalyzer measurements
  5. Able to read and understand questionnaires and informed consent
  6. Lives within approximately 50 miles of the study site

Exclusion Criteria

  1. Currently meets DSM IV criteria for any other psychoactive substance dependence disorder except nicotine dependence
  2. Any psychoactive substance abuse, except marijuana, nicotine, and cocaine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen. May meet cocaine abuse criteria, but not dependence, and also must have two sequential urines free of illicit substances
  3. Meets DSM IV criteria for current and active axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder
  4. Meets DSM IV current criteria for dissociative disorder or eating disorders
  5. Has current suicidal ideation or homicidal ideation
  6. Need for maintenance or acute treatment with any psychoactive medication, except a stable dose (at least one month) of antidepressants
  7. Need for maintenance on anti-seizure medications (including topiramate and gabapentin)
  8. Use of disulfiram, acamprosate, or naltrexone in the last two weeks
  9. Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion
  10. Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days abstinence
  11. Sexually active female of child-bearing potential who is pregnant (by urine HCG), nursing, or who is not willing to use a reliable form of birth control
  12. Has current charges pending for a violent crime (not including DUI-related offenses)
  13. Does not have a stable living situation
  14. African American heritage due to low prevalence of Asp40 (also see Inclusion of Women and Minorities section)

Exclusion Criteria of fMRI Procedure

  1. Having metal objects in the body that are deemed unsafe in the MRI environment.
  2. Severe claustrophobia that cannot be managed with support and encouragement.
  3. Morbid obesity such that placement in the MRI scanner is impossible.
  4. History of significant head injury leading to unconsciousness.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00920829
Other Study ID Numbers  ICMJE ANTON-1R01AA017633-01A1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Raymond F Anton, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP