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Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

Primary Purpose

Cannabis Dependence, Alcohol Dependence, Cannabis Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aprepitant
Placebo
Manual-guided behavioral counseling
Sponsored by
The Scripps Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring Cannabis Treatment, Alcohol Treatment, Alcohol-Related Disorders, Cannabis-Related Disorders, Substance-Related Disorders, Emend, NK1 receptor antagonist, Alcohol, Cannabis, aprepitant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or females from 18-70 years of age
  • Meets DSM IV criteria for current alcohol and cannabis dependence
  • Seeking research-based outpatient treatment for alcohol and cannabis dependence that involves daily oral medication
  • Negative BAC and a CIWA score < 9 at randomization

Exclusion Criteria:

  • Significant medical disorders or use of medications that will increase potential risk or influence study outcomes
  • Females who are pregnant, nursing or who are sexually active with child-bearing potential and refuse to use an effective, non hormonal method of birth control during the study and for up to 4 weeks after study termination• Treatment with an investigational drug during the previous month
  • Prior treatment with NK1 antagonists
  • Participants for whom treatment is being mandated by a legal authority• Inability to understand and/or comply with the provisions of the protocol and consent form

Sites / Locations

  • The Scripps Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental: aprepitant 125 mg/day

Placebo 125mg/d

Arm Description

125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.

Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.

Outcomes

Primary Outcome Measures

Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8
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).
Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8
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.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2014
Last Updated
July 5, 2017
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02210195
Brief Title
Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
Official Title
Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 4, 2014 (Actual)
Primary Completion Date
December 19, 2016 (Actual)
Study Completion Date
December 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of the supplemental study is to provide POC testing of aprepitant as a treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in the parent grant will likewise be applied to the supplemental project to test for effects of aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The primary hypothesis is that subjects treated with aprepitant will have significantly less alcohol and marijuana use than subjects treated with placebo.
Detailed Description
Consistent with the scope and methods of the parent grant, this was a randomized, double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical trial of aprepitant 125 mg/d or placebo. Participants were 20 outpatients seeking treatment for concurrent alcohol and cannabis dependence. All participants received weekly protocol-specific counseling. Research assessments occurred weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments occurred at Weeks 9 and 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence, Alcohol Dependence, Cannabis Use Disorder, Alcohol Use Disorder
Keywords
Cannabis Treatment, Alcohol Treatment, Alcohol-Related Disorders, Cannabis-Related Disorders, Substance-Related Disorders, Emend, NK1 receptor antagonist, Alcohol, Cannabis, aprepitant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: aprepitant 125 mg/day
Arm Type
Active Comparator
Arm Description
125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Arm Title
Placebo 125mg/d
Arm Type
Placebo Comparator
Arm Description
Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Intervention Type
Drug
Intervention Name(s)
aprepitant
Other Intervention Name(s)
Emend
Intervention Description
125 mg daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo daily for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Manual-guided behavioral counseling
Other Intervention Name(s)
Manual-guided therapy
Intervention Description
Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.
Primary Outcome Measure Information:
Title
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8
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
Title
Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females from 18-70 years of age Meets DSM IV criteria for current alcohol and cannabis dependence Seeking research-based outpatient treatment for alcohol and cannabis dependence that involves daily oral medication Negative BAC and a CIWA score < 9 at randomization Exclusion Criteria: Significant medical disorders or use of medications that will increase potential risk or influence study outcomes Females who are pregnant, nursing or who are sexually active with child-bearing potential and refuse to use an effective, non hormonal method of birth control during the study and for up to 4 weeks after study termination• Treatment with an investigational drug during the previous month Prior treatment with NK1 antagonists Participants for whom treatment is being mandated by a legal authority• Inability to understand and/or comply with the provisions of the protocol and consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J. Mason, Ph.D.
Organizational Affiliation
The Scripps Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Scripps Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

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