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Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

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ClinicalTrials.gov Identifier: NCT02210195
Recruitment Status : Completed
First Posted : August 6, 2014
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cannabis Dependence
Alcohol Dependence
Cannabis Use Disorder
Alcohol Use Disorder
Interventions Drug: aprepitant
Drug: Placebo
Behavioral: Manual-guided behavioral counseling
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aprepitant: 125mg/Day Matched Placebo
Hide Arm/Group Description 125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Period Title: Overall Study
Started 10 10
Completed 6 10
Not Completed 4 0
Arm/Group Title Aprepitant: 125mg/Day Matched Placebo Total
Hide Arm/Group Description 125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
34.5  (13.5) 35.5  (9.3) 35.0  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
2
  20.0%
1
  10.0%
3
  15.0%
Male
8
  80.0%
9
  90.0%
17
  85.0%
1.Primary Outcome
Title Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8
Hide Description 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).
Time Frame Week 0 and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aprepitant: 125mg/Day Matched Placebo
Hide Arm/Group Description:
125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Overall Number of Participants Analyzed 6 10
Mean (Standard Deviation)
Unit of Measure: ng/mg
198.3  (389.4) 55.9  (239.3)
2.Primary Outcome
Title Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8
Hide Description Standard 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.
Time Frame Week 0 and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aprepitant: 125mg/Day Matched Placebo
Hide Arm/Group Description:
125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Overall Number of Participants Analyzed 6 10
Mean (Standard Deviation)
Unit of Measure: drinks/week
-21.0  (16.1) -10.7  (17.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aprepitant: 125mg/Day Matched Placebo
Hide Arm/Group Description 125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
All-Cause Mortality
Aprepitant: 125mg/Day Matched Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aprepitant: 125mg/Day Matched Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aprepitant: 125mg/Day Matched Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/10 (60.00%)   6/10 (60.00%) 
Gastrointestinal disorders     
Faeces discoloured  1  0/10 (0.00%)  1/10 (10.00%) 
Frequent bowel movements  1  0/10 (0.00%)  1/10 (10.00%) 
Nausea  1  2/10 (20.00%)  0/10 (0.00%) 
Toothache  1  0/10 (0.00%)  1/10 (10.00%) 
Vomiting  1  0/10 (0.00%)  1/10 (10.00%) 
Infections and infestations     
Nasopharyngitis  1  3/10 (30.00%)  1/10 (10.00%) 
Injury, poisoning and procedural complications     
Foreign body in eye  1  1/10 (10.00%)  0/10 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/10 (10.00%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders     
Neck pain  1  1/10 (10.00%)  0/10 (0.00%) 
Back pain  1  1/10 (10.00%)  1/10 (10.00%) 
Pain in extremity  1  0/10 (0.00%)  1/10 (10.00%) 
Pain in jaw  1  1/10 (10.00%)  0/10 (0.00%) 
Nervous system disorders     
Dizziness  1  1/10 (10.00%)  0/10 (0.00%) 
Headache  1  1/10 (10.00%)  0/10 (0.00%) 
Syncope  1  1/10 (10.00%)  0/10 (0.00%) 
Psychiatric disorders     
Depression  1  1/10 (10.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  1  0/10 (0.00%)  1/10 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr. Barbara Mason
Organization: The Scripps Research Institute
Phone: (858) 784-7324
Responsible Party: Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT02210195     History of Changes
Other Study ID Numbers: DA030988-04S1
R01DA030988-04S1 ( U.S. NIH Grant/Contract )
First Submitted: July 31, 2014
First Posted: August 6, 2014
Results First Submitted: July 5, 2017
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017