Trial Outcomes & Findings for Treatment for Cannabis Withdrawal and Dependence (NCT NCT01611948)
NCT ID: NCT01611948
Last Updated: 2017-05-01
Results Overview
Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).
COMPLETED
PHASE2
70 participants
Week 0 and Week 8
2017-05-01
Participant Flow
Participant milestones
| Measure |
Aprepitant: 125mg/Day
125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
Matched Placebo
Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
38
|
|
Overall Study
COMPLETED
|
18
|
26
|
|
Overall Study
NOT COMPLETED
|
14
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment for Cannabis Withdrawal and Dependence
Baseline characteristics by cohort
| Measure |
Aprepitant: 125mg/Day
n=32 Participants
125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
Matched Placebo
n=38 Participants
Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.09 years
STANDARD_DEVIATION 10.62 • n=93 Participants
|
30.50 years
STANDARD_DEVIATION 12.19 • n=4 Participants
|
31.69 years
STANDARD_DEVIATION 11.49 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 0 and Week 8Population: Two participants in the matched placebo arm who completed the double blind portion of the trial were unable to be analyzed for change in Urinary CN-THCCOOH Level due to missing data at Week 0 and/or Week 8. One sample was missing source documentation while the other sample was too dilute to return a reliable measurement.
Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).
Outcome measures
| Measure |
Aprepitant: 125mg/Day
n=18 Participants
125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
Matched Placebo
n=24 Participants
Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
|---|---|---|
|
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8
|
-334.21 ng/mg
Standard Deviation 718.83
|
-359.95 ng/mg
Standard Deviation 1207.47
|
Adverse Events
Aprepitant: 125mg/Day
Matched Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aprepitant: 125mg/Day
n=32 participants at risk
125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
Matched Placebo
n=38 participants at risk
Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
|---|---|---|
|
Gastrointestinal disorders
Consipation
|
6.2%
2/32
|
2.6%
1/38
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
1/32
|
5.3%
2/38
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/32
|
5.3%
2/38
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
2/32
|
2.6%
1/38
|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32
|
5.3%
2/38
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32
|
7.9%
3/38
|
|
General disorders
Fatigue
|
0.00%
0/32
|
7.9%
3/38
|
|
Infections and infestations
Gastroenteritis viral
|
6.2%
2/32
|
2.6%
1/38
|
|
Infections and infestations
Nasopharyngitis
|
15.6%
5/32
|
31.6%
12/38
|
|
Injury, poisoning and procedural complications
Joint injury
|
3.1%
1/32
|
5.3%
2/38
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/32
|
10.5%
4/38
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32
|
2.6%
1/38
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
2/32
|
0.00%
0/38
|
|
Nervous system disorders
Dizziness
|
0.00%
0/32
|
5.3%
2/38
|
|
Nervous system disorders
Headache
|
18.8%
6/32
|
10.5%
4/38
|
|
Nervous system disorders
Somnolence
|
9.4%
3/32
|
7.9%
3/38
|
|
Psychiatric disorders
Insomnia
|
3.1%
1/32
|
7.9%
3/38
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32
|
5.3%
2/38
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/32
|
7.9%
3/38
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place