Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

The Scripps Research Institute20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cannabis Dependence Alcohol Dependence

Interventions

aprepitantDRUG

125 mg daily for 8 weeks.

PlaceboDRUG

Placebo daily for 8 weeks.

Manual-guided behavioral counselingBEHAVIORAL

Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Week 0 and Week 8

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.