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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
Enrollment 358
Recruitment Details 358 Subjects were recruited via media advertisements and clinical referrals and 355 provided a blood sample for A118G genotyping.
Pre-assignment Details 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.
Arm/Group Title A118G A/A With Naltrexone A118G A/A With Placebo A118G Any G With Naltrexone A118G Any G With Placebo
Hide Arm/Group Description

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

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

Placebo: placebo

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

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

Period Title: Allocation
Started 38 39 38 37
Completed 35 38 38 35
Not Completed 3 1 0 2
Reason Not Completed
No post randomization data             3             1             0             2
Period Title: Available for Analysis
Started 35 38 38 35
Completed 27 27 28 24
Not Completed 8 11 10 11
Reason Not Completed
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
Arm/Group Title A118G A/A With Naltrexone A118G A/A With Placebo A118G Any G With Naltrexone A118G Any G With Placebo Total
Hide Arm/Group Description

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

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

Placebo: placebo

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

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 of all reporting groups
Overall Number of Baseline Participants 35 38 38 35 146
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 38 participants 38 participants 35 participants 146 participants
51.1  (8.2) 46.3  (10.8) 50.3  (10.2) 49.7  (10.6) 49.3  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 38 participants 38 participants 35 participants 146 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 38 participants 38 participants 35 participants 146 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%
1.Primary Outcome
Title Percent Heavy Drinking Days by mu Opioid Receptor Gene
Hide Description [Not Specified]
Time Frame Time Line Follow-Back drinking collected at each of 9 visits (weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A118G A/A With Naltrexone A118G A/A With Placebo A118G Any G With Naltrexone A118G Any G With Placebo
Hide Arm/Group Description:

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

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

Placebo: placebo

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

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

Overall Number of Participants Analyzed 35 38 38 35
Mean (Standard Error)
Unit of Measure: percentage of days
Month 1 11.0  (3.5) 18.0  (3.4) 11.8  (3.4) 18.7  (3.6)
Month 2 11.7  (4.5) 25.8  (4.4) 15.5  (4.4) 19.7  (4.5)
Month 3 10.4  (4.4) 23.0  (4.3) 16.9  (4.3) 25.0  (4.4)
Month 4 11.4  (4.7) 18.1  (4.5) 18.3  (4.5) 28.7  (4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A118G A/A With Naltrexone, A118G A/A With Placebo, A118G Any G With Naltrexone, A118G Any G With Placebo
Comments A linear mixed model with unstructured variance/covariance matrices was used to evaluate the primary outcome measure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.724
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A118G A/A With Naltrexone, A118G A/A With Placebo, A118G Any G With Naltrexone, A118G Any G With Placebo
Comments This is a test of the main effect of medication, with a null hypothesis of no difference between Naltrexone and Placebo groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Number of subjects responding positively to queries in the SAFTEE instrument.
 
Arm/Group Title Placebo/ASN Placebo/ASP Naltrexone/ASN Naltrexone/ASP
Hide Arm/Group Description ASN subjects given placebo ASP subjects given placebo ASN subjects given naltrexone ASP subjects given naltrexone
All-Cause Mortality
Placebo/ASN Placebo/ASP Naltrexone/ASN Naltrexone/ASP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)      0/35 (0.00%)      0/35 (0.00%)      1/38 (2.63%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo/ASN Placebo/ASP Naltrexone/ASN Naltrexone/ASP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/35 (0.00%)      0/35 (0.00%)      0/38 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo/ASN Placebo/ASP Naltrexone/ASN Naltrexone/ASP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/38 (42.11%)      20/35 (57.14%)      30/35 (85.71%)      29/38 (76.32%)    
Gastrointestinal disorders         
Nausea   9/38 (23.68%)  9 9/35 (25.71%)  14 22/35 (62.86%)  27 13/38 (34.21%)  26
Diarrhea   6/38 (15.79%)  8 9/35 (25.71%)  19 18/35 (51.43%)  28 16/38 (42.11%)  35
abdominal pain   4/38 (10.53%)  6 5/35 (14.29%)  17 11/35 (31.43%)  22 16/38 (42.11%)  32
General disorders         
dizziness   6/38 (15.79%)  7 9/35 (25.71%)  21 14/35 (40.00%)  26 14/38 (36.84%)  24
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Raymond Anton
Organization: Medical University of South Carolina
Phone: 843-792-1226
EMail: antonr@musc.edu
Layout table for additonal information
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