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A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana

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ClinicalTrials.gov Identifier: NCT01005810
Recruitment Status : Completed
First Posted : November 2, 2009
Results First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kevin Gray, MD, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cannabis Dependence
Interventions Drug: N-Acetylcysteine
Drug: placebo
Behavioral: Contingency Management
Enrollment 116
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description

N-Acetylcysteine : 1200 mg twice daily for 8 weeks

Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

placebo : 2 capsules twice daily for 8 weeks

Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

Period Title: Overall Study
Started 58 58
Completed 37 33
Not Completed 21 25
Arm/Group Title N-Acetylcysteine Placebo Total
Hide Arm/Group Description

N-Acetylcysteine : 1200 mg twice daily for 8 weeks

Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

placebo : 2 capsules twice daily for 8 weeks

Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

Total of all reporting groups
Overall Number of Baseline Participants 58 58 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 116 participants
<=18 years
9
  15.5%
9
  15.5%
18
  15.5%
Between 18 and 65 years
49
  84.5%
49
  84.5%
98
  84.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 58 participants 116 participants
18.9  (1.5) 18.8  (1.5) 18.9  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 116 participants
Female
19
  32.8%
13
  22.4%
32
  27.6%
Male
39
  67.2%
45
  77.6%
84
  72.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 58 participants 58 participants 116 participants
58
 100.0%
58
 100.0%
116
 100.0%
1.Primary Outcome
Title Percentage of Negative Urine Cannabinoid Tests During Treatment
Hide Description [Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100
Time Frame weekly during treatment, for 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description:

N-Acetylcysteine : 1200 mg twice daily for 8 weeks

Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

placebo : 2 capsules twice daily for 8 weeks

Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

Overall Number of Participants Analyzed 58 58
Measure Type: Number
Unit of Measure: percentage of negative urine tests
40.9 27.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N-Acetylcysteine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.35
Confidence Interval (2-Sided) 95%
1.05 to 5.24
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description

N-Acetylcysteine: 1200 mg twice daily for 8 weeks

Contingency Management: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

placebo: 2 capsules twice daily for 8 weeks

Contingency Management: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

All-Cause Mortality
N-Acetylcysteine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)      0/58 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
N-Acetylcysteine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/58 (0.00%)      0/58 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N-Acetylcysteine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/58 (41.38%)      27/58 (46.55%)    
Gastrointestinal disorders     
Abdominal pain   2/58 (3.45%)  2 1/58 (1.72%)  1
Decreased appetite   1/58 (1.72%)  1 3/58 (5.17%)  3
Heartburn   1/58 (1.72%)  1 0/58 (0.00%)  0
Nausea   0/58 (0.00%)  0 2/58 (3.45%)  2
Infections and infestations     
Upper Respiratory Infection   11/58 (18.97%)  11 8/58 (13.79%)  8
Conjunctivitis   1/58 (1.72%)  1 0/58 (0.00%)  0
Nervous system disorders     
Drowsiness   2/58 (3.45%)  2 2/58 (3.45%)  2
Headache   1/58 (1.72%)  1 3/58 (5.17%)  3
Psychiatric disorders     
Insomnia   5/58 (8.62%)  5 8/58 (13.79%)  8
Irritability   1/58 (1.72%)  1 4/58 (6.90%)  4
Vivid dreams   6/58 (10.34%)  6 2/58 (3.45%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Kevin M. Gray, Associate Professor
Organization: Medical University of South Carolina
Phone: 843-792-6330
Responsible Party: Kevin Gray, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01005810     History of Changes
Other Study ID Numbers: 19152
R01DA026777 ( U.S. NIH Grant/Contract )
First Submitted: September 10, 2009
First Posted: November 2, 2009
Results First Submitted: April 23, 2018
Results First Posted: November 21, 2018
Last Update Posted: November 21, 2018