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Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment (ACCENT)

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: NCT01675661
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : March 8, 2017
Last Update Posted : May 24, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cannabis Dependence
Interventions Drug: N-Acetylcysteine
Drug: Placebo
Enrollment 302
Recruitment Details Recruitment occurred almost exclusively through advertising. Individuals currently in treatment for cannabis dependence were not eligible to participate
Pre-assignment Details  
Arm/Group Title NAC Plus CM Placebo Plus CM
Hide Arm/Group Description

N-acetylcysteine (NAC) plus Contingency Management (CM)

N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Placebo plus Contingency Management (CM)

Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Period Title: Overall Study
Started 153 149
Completed 113 103
Not Completed 40 46
Reason Not Completed
Lost to Follow-up             22             23
Practical problems             9             5
Moved away             5             6
Withdrawal by Subject             3             7
Physician Decision             0             2
Death             0             1
Other reason             1             2
Arm/Group Title NAC Plus CM Placebo Plus CM Total
Hide Arm/Group Description

N-acetylcysteine (NAC) plus Contingency Management (CM)

N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Placebo plus Contingency Management (CM)

Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Total of all reporting groups
Overall Number of Baseline Participants 153 149 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 149 participants 302 participants
29.8  (8.74) 30.8  (9.32) 30.3  (9.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 149 participants 302 participants
Female
36
  23.5%
50
  33.6%
86
  28.5%
Male
117
  76.5%
99
  66.4%
216
  71.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 149 participants 302 participants
Hispanic or Latino
31
  20.3%
34
  22.8%
65
  21.5%
Not Hispanic or Latino
122
  79.7%
115
  77.2%
237
  78.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 149 participants 302 participants
American Indian or Alaska Native
0
   0.0%
2
   1.3%
2
   0.7%
Asian
1
   0.7%
2
   1.3%
3
   1.0%
Native Hawaiian or Other Pacific Islander
1
   0.7%
0
   0.0%
1
   0.3%
Black or African American
44
  28.8%
40
  26.8%
84
  27.8%
White
84
  54.9%
92
  61.7%
176
  58.3%
More than one race
13
   8.5%
6
   4.0%
19
   6.3%
Unknown or Not Reported
10
   6.5%
7
   4.7%
17
   5.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 153 participants 149 participants 302 participants
153 149 302
1.Primary Outcome
Title The Odds of Negative Urine Cannabinoid Tests During Treatment.
Hide Description The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.
Time Frame study weeks 2-13
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat; all participants randomized
Arm/Group Title NAC Plus CM Placebo Plus CM
Hide Arm/Group Description:

N-acetylcysteine (NAC) plus Contingency Management (CM)

N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Placebo plus Contingency Management (CM)

Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Overall Number of Participants Analyzed 153 149
Measure Type: Number
Unit of Measure: cannabis negative urine tests
Study Week 2 25 21
Study Week 3 30 22
Study Week 4 33 36
Study Week 5 32 33
Study Week 6 32 30
Study Week 7 36 37
Study Week 8 40 37
Study Week 9 39 36
Study Week 10 39 37
Study Week 11 38 36
Study Week 12 34 40
Study Week 13 33 36
Overall 410 401
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAC Plus CM, Placebo Plus CM
Comments For the primary outcome measure, a repeated-measures logistic regression model was used to analyze the odds of a negative urine cannabinoid test as an indicator of abstinence across all 12 weeks of treatment. A generalized estimating equations (GEEs) were used to adjust for this correlation with multiple samples per participant. The model for the primary analysis included the main effect of treatment, main effect of time, site effects, effect of smoking tobacco, and timeXtreatment interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.985
Comments [Not Specified]
Method Regression, Logistic
Comments OR=1.00
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.63 to 1.59
Estimation Comments [Not Specified]
Time Frame Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Adverse Event Reporting Description Participants were asked once a week
 
Arm/Group Title NAC Plus CM Placebo Plus CM
Hide Arm/Group Description

N-acetylcysteine (NAC) plus Contingency Management (CM)

N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Placebo plus Contingency Management (CM)

Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

All-Cause Mortality
NAC Plus CM Placebo Plus CM
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NAC Plus CM Placebo Plus CM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/153 (0.65%)      6/149 (4.03%)    
Cardiac disorders     
Irregular Heart Rate  1 [1]  0/153 (0.00%)  0 1/149 (0.67%)  1
Infections and infestations     
Cellulitis  1 [2]  1/153 (0.65%)  1 0/149 (0.00%)  0
Injury, poisoning and procedural complications     
Road Traffic Accident  1 [3]  0/153 (0.00%)  0 1/149 (0.67%)  1
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1 [4]  0/153 (0.00%)  0 1/149 (0.67%)  1
Psychiatric disorders     
Suicidal ideation  1 [5]  0/153 (0.00%)  0 1/149 (0.67%)  1
Reproductive system and breast disorders     
Dysfunctional Uterine Bleeding  1 [6]  0/153 (0.00%)  0 1/149 (0.67%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1 [7]  0/153 (0.00%)  0 1/149 (0.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
[1]
Inpatient admission for irregular heart beat; resolved without sequelae
[2]
Inpatient admission for lower extremity cellulitis-resolved without sequelae
[3]
Death due to motor vehicle accident
[4]
Inpatient hospitalization for herniated disc; resolved without sequelae
[5]
Inpatient hospitalization for suicidal ideation; resolved without sequelae
[6]
Inpatient hospitalization for dysfunctional uterine bleeding; resolved without sequelae
[7]
Inpatient hospitalization for acute exacerbation of asthma
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
NAC Plus CM Placebo Plus CM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/153 (26.14%)      45/149 (30.20%)    
Gastrointestinal disorders     
Nausea  1  7/153 (4.58%)  7 10/149 (6.71%)  10
Diarrhea  1  8/153 (5.23%)  8 8/149 (5.37%)  8
Abdominal discomfort  1  3/153 (1.96%)  3 5/149 (3.36%)  5
Dyspepsia  1  3/153 (1.96%)  3 1/149 (0.67%)  1
Flatulence  1  0/153 (0.00%)  0 2/149 (1.34%)  2
Gastrointestinal disorder  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Frequent Bowel Movements  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Dry mouth  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Abdominal pain  1  2/153 (1.31%)  2 0/149 (0.00%)  0
Vomiting  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Toothache  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Reflux disease  1  1/153 (0.65%)  1 1/149 (0.67%)  1
Hemorrhoids  1  0/153 (0.00%)  0 1/149 (0.67%)  1
General disorders     
Fatigue  1  2/153 (1.31%)  2 2/149 (1.34%)  2
Feeling abnormal  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Energy increased  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Chest pain  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Immune system disorders     
Hypersensitivity  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Infections and infestations     
Urinary tract infection  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Localized infection  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Groin Abscess  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Gastroenteritis viral  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Acute sinusitis  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Injury, poisoning and procedural complications     
Road traffic accident  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Ligament rupture  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Human bite  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Hand Fracture  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Fall  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Back Injury  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Arthropod bite  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Investigations     
Blood pressure increased  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Metabolism and nutrition disorders     
Failure to thrive  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Dehydration  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Nervous system disorders     
Headache  1  10/153 (6.54%)  10 15/149 (10.07%)  15
Dizziness  1  1/153 (0.65%)  1 2/149 (1.34%)  2
Psychiatric disorders     
Insomnia  1  2/153 (1.31%)  2 1/149 (0.67%)  1
Suicidal Ideation  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Panic attack  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Elevated mood  1  0/153 (0.00%)  0 1/149 (0.67%)  1
Depression  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Alcohol abuse  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritis  1  3/153 (1.96%)  3 0/149 (0.00%)  0
Rash  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Vascular disorders     
Hypertension  1  0/153 (0.00%)  0 2/149 (1.34%)  2
Flushing  1  1/153 (0.65%)  1 0/149 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
All publications/dissemination products must be reviewed and approved by the Center for Clinical Trials Network (CCTN) Publications Committee before publishing/disseminating.
Results Point of Contact
Name/Title: Kevin Gray, MD
Organization: Medical University of South Carolina
Phone: 843-792-6330
Responsible Party: Kevin Gray, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01675661     History of Changes
Other Study ID Numbers: CTN-0053
U10DA013727 ( U.S. NIH Grant/Contract )
UG1DA013727 ( U.S. NIH Grant/Contract )
U10DA013045 ( U.S. NIH Grant/Contract )
U10DA015815 ( U.S. NIH Grant/Contract )
U10DA013732 ( U.S. NIH Grant/Contract )
U10DA015831 ( U.S. NIH Grant/Contract )
U10DA020024 ( U.S. NIH Grant/Contract )
First Submitted: August 19, 2012
First Posted: August 30, 2012
Results First Submitted: January 18, 2017
Results First Posted: March 8, 2017
Last Update Posted: May 24, 2018