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N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

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: NCT00332605
Recruitment Status : Completed
First Posted : June 1, 2006
Results First Posted : July 24, 2013
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Methamphetamine Dependence
Interventions Drug: Naltrexone plus N-Acetyl Cysteine
Drug: Placebo
Enrollment 45
Recruitment Details July 2006 - September 2009
Pre-assignment Details  
Arm/Group Title Naltrexone N-Acetyl Cysteine Placebo
Hide Arm/Group Description Naltrexone tablets - 50mg pills taken by mouth daily 600mg tablets taken by mouth daily [Not Specified]
Period Title: Overall Study
Started 14 14 17
Completed 12 12 9
Not Completed 2 2 8
Arm/Group Title Naltrexone N-Acetyl Cysteine Placebo Total
Hide Arm/Group Description Naltrexone tablets - 50mg pills taken by mouth daily 600mg tablets taken by mouth daily [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 14 14 17 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 17 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
14
 100.0%
17
 100.0%
45
 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 14 participants 14 participants 17 participants 45 participants
37  (8.2) 37.2  (8.1) 36.1  (6.6) 36.9  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 17 participants 45 participants
Female
6
  42.9%
6
  42.9%
3
  17.6%
15
  33.3%
Male
8
  57.1%
8
  57.1%
14
  82.4%
30
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 17 participants 45 participants
14 14 17 45
1.Primary Outcome
Title Penn Craving Scale
Hide Description used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome.
Time Frame beginning and at each visit until the end of their participation in the study
Hide Outcome Measure Data
Hide Analysis Population Description
Reported scores are Mean and standard deviation for Subjects last visit (including last-observation carried forward).
Arm/Group Title Naltrexone N-Acetyl Cysteine Placebo
Hide Arm/Group Description:
Naltrexone tablets
600mg tablets, daily
Placebo capsules
Overall Number of Participants Analyzed 14 14 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
24.0  (5.5) 24.0  (5.4) 21.1  (6.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naltrexone N-Acetyl Cysteine Placebo
Hide Arm/Group Description Naltrexone tablets - 50mg pills taken by mouth daily 600mg tablets taken by mouth daily [Not Specified]
All-Cause Mortality
Naltrexone N-Acetyl Cysteine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Naltrexone N-Acetyl Cysteine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)      0/17 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naltrexone N-Acetyl Cysteine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/14 (57.14%)      8/14 (57.14%)      7/17 (41.18%)    
Gastrointestinal disorders       
Nausea   8/14 (57.14%)  8 8/14 (57.14%)  8 7/17 (41.18%)  7
General disorders       
Lethargy *  0/14 (0.00%)  0 0/14 (0.00%)  0 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-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: Jon E. Grant
Organization: University of Chicago
Phone: 773-834-1325
EMail: jongrant@uchicago.edu
Layout table for additonal information
Responsible Party: Jon Grant, University of Minnesota
ClinicalTrials.gov Identifier: NCT00332605    
Other Study ID Numbers: 0601M80486
First Submitted: May 30, 2006
First Posted: June 1, 2006
Results First Submitted: March 1, 2012
Results First Posted: July 24, 2013
Last Update Posted: November 30, 2017