Trial Outcomes & Findings for A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana (NCT NCT01005810)
NCT ID: NCT01005810
Last Updated: 2018-11-21
Results Overview
\[Total number of negative urine tests per Group divided by the total number of urine tests per Group\]\*100
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
weekly during treatment, for 8 weeks
Results posted on
2018-11-21
Participant Flow
Participant milestones
| Measure |
N-Acetylcysteine
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
placebo : 2 capsules twice daily for 8 weeks
Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
|
Overall Study
COMPLETED
|
37
|
33
|
|
Overall Study
NOT COMPLETED
|
21
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
Baseline characteristics by cohort
| Measure |
N-Acetylcysteine
n=58 Participants
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
n=58 Participants
placebo : 2 capsules twice daily for 8 weeks
Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
18.9 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
18.8 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
18.9 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weekly during treatment, for 8 weeks\[Total number of negative urine tests per Group divided by the total number of urine tests per Group\]\*100
Outcome measures
| Measure |
N-Acetylcysteine
n=58 Participants
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
n=58 Participants
placebo : 2 capsules twice daily for 8 weeks
Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
|
|---|---|---|
|
Percentage of Negative Urine Cannabinoid Tests During Treatment
|
40.9 percentage of negative urine tests
|
27.2 percentage of negative urine tests
|
Adverse Events
N-Acetylcysteine
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N-Acetylcysteine
n=58 participants at risk
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
n=58 participants at risk
placebo: 2 capsules twice daily for 8 weeks
Contingency Management: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Infection
|
19.0%
11/58 • Number of events 11
|
13.8%
8/58 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
2/58 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
1.7%
1/58 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Decreased appetite
|
1.7%
1/58 • Number of events 1
|
5.2%
3/58 • Number of events 3
|
|
Nervous system disorders
Drowsiness
|
3.4%
2/58 • Number of events 2
|
3.4%
2/58 • Number of events 2
|
|
Gastrointestinal disorders
Heartburn
|
1.7%
1/58 • Number of events 1
|
0.00%
0/58
|
|
Nervous system disorders
Headache
|
1.7%
1/58 • Number of events 1
|
5.2%
3/58 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
8.6%
5/58 • Number of events 5
|
13.8%
8/58 • Number of events 8
|
|
Psychiatric disorders
Irritability
|
1.7%
1/58 • Number of events 1
|
6.9%
4/58 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/58
|
3.4%
2/58 • Number of events 2
|
|
Psychiatric disorders
Vivid dreams
|
10.3%
6/58 • Number of events 6
|
3.4%
2/58 • Number of events 2
|
Additional Information
Dr. Kevin M. Gray, Associate Professor
Medical University of South Carolina
Phone: 843-792-6330
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place