Trial Outcomes & Findings for Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence (NCT NCT02210195)
NCT ID: NCT02210195
Last Updated: 2017-08-02
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
20 participants
Week 0 and Week 8
2017-08-02
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
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
Baseline characteristics by cohort
| Measure |
Aprepitant: 125mg/Day
n=10 Participants
125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
Matched Placebo
n=10 Participants
Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
35.0 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 and Week 8Urinary 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=6 Participants
125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
Matched Placebo
n=10 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
|
198.3 ng/mg
Standard Deviation 389.4
|
55.9 ng/mg
Standard Deviation 239.3
|
PRIMARY outcome
Timeframe: Week 0 and Week 8Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.
Outcome measures
| Measure |
Aprepitant: 125mg/Day
n=6 Participants
125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
Matched Placebo
n=10 Participants
Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
|---|---|---|
|
Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8
|
-21.0 drinks/week
Standard Deviation 16.1
|
-10.7 drinks/week
Standard Deviation 17.1
|
Adverse Events
Aprepitant: 125mg/Day
Matched Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aprepitant: 125mg/Day
n=10 participants at risk
125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
Matched Placebo
n=10 participants at risk
Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
|
|---|---|---|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10
|
10.0%
1/10
|
|
Infections and infestations
Nasopharyngitis
|
30.0%
3/10
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
10.0%
1/10
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
10.0%
1/10
|
0.00%
0/10
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10
|
0.00%
0/10
|
|
Nervous system disorders
Headache
|
10.0%
1/10
|
0.00%
0/10
|
|
Nervous system disorders
Syncope
|
10.0%
1/10
|
0.00%
0/10
|
|
Psychiatric disorders
Depression
|
10.0%
1/10
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10
|
10.0%
1/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place