Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Memantine and Naltrexone Treatment for Opioid Dependence (NAMHS-1)

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: NCT00125515
Recruitment Status : Completed
First Posted : August 1, 2005
Results First Posted : January 24, 2013
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Adam Bisaga, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Opioid Dependence
Interventions Drug: Memantine
Drug: Naltrexone
Enrollment 81
Recruitment Details Individuals who applied for treatment at the Columbia University's Substance Treatment and Research Service outpatient clinic in New York City were recruited for this study.
Pre-assignment Details Following consent participants were admitted to an inpatient unti at NYSPI for the purpose od detoxification and naltrexone induction. On the second day of induction they were randomized to a study arm.
Arm/Group Title Placebo Memantine 30 mg Bid Memantine 15 mg Bid
Hide Arm/Group Description Placebo plus oral naltrexone Memantine 30 mg bid plus oral naltrexone memantine 15 mg bid plus oral naltrexone
Period Title: Overall Study
Started 27 27 27
Completed 7 7 6
Not Completed 20 20 21
Arm/Group Title Placebo Memantine 30 mg Bid Memantine 15 mg Bid Total
Hide Arm/Group Description Placebo plus oral naltrexone Memantine 30 mg bid plus oral naltrexone memantine 15 mg bid plus oral naltrexone Total of all reporting groups
Overall Number of Baseline Participants 27 27 27 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 27 participants 81 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
27
 100.0%
27
 100.0%
81
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 27 participants 27 participants 81 participants
40.5  (9.6) 42.0  (10.3) 41.5  (9.4) 41.3  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 27 participants 81 participants
Female
7
  25.9%
5
  18.5%
3
  11.1%
15
  18.5%
Male
20
  74.1%
22
  81.5%
24
  88.9%
66
  81.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 27 participants 27 participants 81 participants
27 27 27 81
1.Primary Outcome
Title Retention in Treatment
Hide Description The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.
Time Frame Number of participants who complete 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All analysis were conducted based on intent-to-treat principle.
Arm/Group Title Placebo Memantine 30 mg Bid Memantine 15 mg Bid
Hide Arm/Group Description:
Placebo plus oral naltrexone
Memantine 30 mg bid plus oral naltrexone
memantine 15 mg bid plus oral naltrexone
Overall Number of Participants Analyzed 27 27 27
Measure Type: Number
Unit of Measure: participants
7 5 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine 30 mg Bid, Memantine 15 mg Bid
Comments all statistical analysis were two tailed and employed an alpha significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Memantine 30 mg Bid Memantine 15 mg Bid
Hide Arm/Group Description Placebo plus oral naltrexone Memantine 30 mg bid plus oral naltrexone memantine 15 mg bid plus oral naltrexone
All-Cause Mortality
Placebo Memantine 30 mg Bid Memantine 15 mg Bid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Memantine 30 mg Bid Memantine 15 mg Bid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/27 (0.00%)      1/27 (3.70%)    
General disorders       
heroin overdose  [1]  0/27 (0.00%)  0 0/27 (0.00%)  0 1/27 (3.70%)  1
Indicates events were collected by systematic assessment
[1]
Overdose requiring hospitalization following relapse to heroin use.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Memantine 30 mg Bid Memantine 15 mg Bid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/27 (59.26%)      17/27 (62.96%)      10/27 (37.04%)    
Gastrointestinal disorders       
nausea   1/27 (3.70%)  1 5/27 (18.52%)  5 1/27 (3.70%)  1
diarrhea   4/27 (14.81%)  4 4/27 (14.81%)  4 2/27 (7.41%)  2
GI distress   7/27 (25.93%)  7 7/27 (25.93%)  7 0/27 (0.00%)  0
General disorders       
headache   5/27 (18.52%)  5 3/27 (11.11%)  3 2/27 (7.41%)  2
insomnia   7/27 (25.93%)  7 9/27 (33.33%)  9 8/27 (29.63%)  8
body aches   2/27 (7.41%)  2 2/27 (7.41%)  2 1/27 (3.70%)  1
dizziness   3/27 (11.11%)  3 2/27 (7.41%)  2 2/27 (7.41%)  2
weakness   1/27 (3.70%)  1 1/27 (3.70%)  1 3/27 (11.11%)  3
Indicates events were collected by systematic assessment
It is possible that concomitant naltrexone might have exacerbated protracted withdrawal, thus masking the potential ameliorative effects of memantine that have been previously observed in other trials.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Adam Bisaga
Organization: New York Psychiatric Institute
Phone: 212-543-6542
Responsible Party: Adam Bisaga, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00125515     History of Changes
Other Study ID Numbers: #4847/R01-15822
K23DA000429 ( U.S. NIH Grant/Contract )
First Submitted: July 28, 2005
First Posted: August 1, 2005
Results First Submitted: December 18, 2012
Results First Posted: January 24, 2013
Last Update Posted: June 18, 2018