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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Alcohol Dependence
Interventions: Drug: Naltrexone 50 Mg
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
358 Subjects were recruited via media advertisements and clinical referrals and 355 provided a blood sample for A118G genotyping.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A118G genotyping was performed for 355 of these, 259 were A/A (Asn40) allele and 96 were any G (asp). Of the 259 Asn40 subjects, 89 were selected to participate 5 met exclusion criteria and 7 were lost or declined. Of the 96 Asp subjects, 9 met exclusion; 12 were lost or declined.

Reporting Groups
  Description
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

Naltrexone Hydrochloride 50 MG: Naltrexone 25 or 50 mg per tiration schedule

A118G A/A With Placebo

Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks

Placebo: placebo

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

Naltrexone Hydrochloride 50 MG: Naltrexone 25 or 50 mg per tiration schedule

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

Placebo: placebo


Participant Flow for 2 periods

Period 1:   Allocation
    A118G A/A With Naltrexone   A118G A/A With Placebo   A118G Any G With Naltrexone   A118G Any G With Placebo
STARTED   38   39   38   37 
COMPLETED   35   38   38   35 
NOT COMPLETED   3   1   0   2 
No post randomization data                3                1                0                2 

Period 2:   Available for Analysis
    A118G A/A With Naltrexone   A118G A/A With Placebo   A118G Any G With Naltrexone   A118G Any G With Placebo
STARTED   35   38   38   35 
COMPLETED   27   27   28   24 
NOT COMPLETED   8   11   10   11 
Withdrawal by Subject                6                6                6                10 
Required Medical Treatment                0                1                2                0 
Adverse Event                1                2                1                0 
Death                1                0                0                0 
Protocol Violation                0                0                1                0 
Required more treatment                0                2                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Naltrexone 50 MG: Naltrexone 25 or 50 mg per titration schedule

A118G A/A With Placebo

Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks

Placebo: placebo

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

Naltrexone 50 MG: Naltrexone 25 or 50 mg per titration schedule

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

Placebo: placebo

Total Total of all reporting groups

Baseline Measures
   A118G A/A With Naltrexone   A118G A/A With Placebo   A118G Any G With Naltrexone   A118G Any G With Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   38   38   35   146 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.1  (8.2)   46.3  (10.8)   50.3  (10.2)   49.7  (10.6)   49.3  (10.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      9  25.7%      12  31.6%      13  34.2%      11  31.4%      45  30.8% 
Male      26  74.3%      26  68.4%      25  65.8%      24  68.6%      101  69.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      1   2.9%      0   0.0%      0   0.0%      0   0.0%      1   0.7% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      34  97.1%      38 100.0%      38 100.0%      34  97.1%      144  98.6% 
More than one race      0   0.0%      0   0.0%      0   0.0%      1   2.9%      1   0.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Raymond Anton
Organization: Medical University of South Carolina
phone: 843-792-1226
e-mail: antonr@musc.edu


Publications of Results:

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00920829     History of Changes
Other Study ID Numbers: ANTON-1R01AA017633-01A1
First Submitted: June 11, 2009
First Posted: June 15, 2009
Results First Submitted: February 27, 2018
Results First Posted: June 4, 2018
Last Update Posted: July 10, 2018