Medications Development for the Treatment of Cannabis Related Disorders (MTC)

May 31, 2012 updated by: University of Virginia
The primary objective of this application is to test the neurobehavioral mechanisms and effects of aprepitant as a new cessation agent for cannabis, tobacco or both.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stress (emotional, physical, social) facilitates drug seeking behavior through the activation of the HPA axis, autonomic nervous system, and brain DA systems. Furthermore, alterations within several neuropeptide systems (CRF, Substance P, and others) also contribute to the role of stress in addiction. Central to this project is that anxiety and stress responses are modulated by substance P and its preferred target, the NK1 receptor. Therefore the aim of this pilot clinical trial is to determine the safety and efficacy of aprepitant (a neurokinin 1 (NK1) receptor antagonist). We hypothesize that the NK1 receptor antagonist, aprepitant, will be safe, tolerable and efficacious at reducing the withdrawal symptoms, cue craving, and reinforcement value for both cannabis and tobacco resulting from the cessation of either or both drugs. We will assess this hypothesis in the context of a carefully controlled human laboratory study in which subjects (N=72) will be randomized in a 3 x 2 factorial design to one of 3 behavioral conditions; a) withdrawn from both substances, b) withdrawn from tobacco only, or c) withdrawn from cannabis only, and to receive one of 2 medication dose conditions: placebo or aprepitant (160 mg/day). Medication will be administered for 5 days, followed by a cue challenge, choice procedure, and then a consequence (i.e., oral cannabis or a cigarette or money) also on day 5.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Clinical Pharmacological Research Unit (CPRU), University of Virginia School of Medicine
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Center for Addiction Education and Treatment (UVA CARE)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must meet DSM-IV/ICD-10 criteria for cannabis abuse or dependence
  • Must be non-treatment seeking individuals
  • Participant does not meet DSM-IV criteria for any current (i.e., criteria met at any point in the past 30 days) dependence on a substance other than alcohol, nicotine, caffeine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
  • No subjects who have trouble reading the English language or visual or hearing problems that may interfere with the collection of data
  • Not currently taking other medications (with the exception of oral contraceptives) that would preclude safe participation in this study
  • Must test negative for pregnancy prior to inclusion
  • females using birth control pills must agree to use a condom during intercourse for 1 month after participation in study because the study medication will decrease the effectiveness of the birth control pill rendering it ineffective
  • Should be in general good health
  • No evidence of recent use of other illicit drugs on a urine toxicity screen prior to admission

Exclusion Criteria:

  • Major current (within last 90 days) Axis I psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia)
  • Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, cancer, epilepsy, kidney disease)
  • Current, repeated illicit drug use (other than marijuana)
  • Subject is breastfeeding or pregnant
  • Concurrent therapy with drugs known to inhibit CYP3A4 activity
  • Request for drug treatment
  • Current parole or probation
  • Recent history of significant violent or suicide behavior
  • Allergic to sesame oil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Condition 1
Nicotine patch (21 mg) plus placebo oral cannabis (0 mg; 3 times a day on days 2-4, given once on day 5)
Drug: Placebo Aprepitant
Placebo Aprepitant 0 mg once daily for 5 days
Drug: Active Aprepitant
Active Aprepitant 160 mg once daily for 5 days
Experimental: Behavioral Condition 2
Placebo nicotine patch (0 mg) plus oral cannabis (10 mg, 3 times each day, days 2-4, day 5 given once)
Drug: Placebo Aprepitant
Placebo Aprepitant 0 mg once daily for 5 days
Drug: Active Aprepitant
Active Aprepitant 160 mg once daily for 5 days
Experimental: Behavioral Condition 3
Placebo nicotine patch (0 mg) plus placebo oral cannabis (0 mg, 3 times each day days 2-4, day 5 given once)
Drug: Placebo Aprepitant
Placebo Aprepitant 0 mg once daily for 5 days
Drug: Active Aprepitant
Active Aprepitant 160 mg once daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
withdrawal symptom severity, measured on a 0 (not at all) to 3 (severe) scale
Time Frame: collected on each study day
Subjective experience of withdrawal symptoms for cannabis, tobacco, and both (eg: Irritability, Sleep difficulty, Chills, Nervousness)
collected on each study day
"craving" measured using the Marijuana craving questionaire and the tobacco craving questionaire
Time Frame: collected on each study day
Subjective measures of craving for cannabis, tobacco, and both Questionaires are anchored with strongly disagree to strongly agree (1-7)
collected on each study day
reinforcing effects, as measured using the Multiple Choice Questionaire
Time Frame: collected each day of study
Reinforcement value of cannabis and tobacco as measured by preference for money over the administration of either drug; questionaire has 70 questions and money value vs. drug ranges from 25 cents to 25 dollars 1-70.
collected each day of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep quality
Time Frame: collected on each study day
A VAS sleep questionnaire will be used each morning to assess daily sleep quality.
collected on each study day
Neurocognitive Function
Time Frame: collected on days 1-4 of the study
The purpose of examining the neurocognitive function of our participants on days 1-4 is to examine the safety of the co-administration of aprepitant at 160 mg/day with oral THC (dronabinol 10 mg) on brain function. Tasks used are the DSST - The Digit Symbol Substitution Test measures the learning of integrating visual and motor skills, and the SRTT- The Simple reaction Time Task is a well validated computerized test for assessing the effects of psychoactive drugs on performance.
collected on days 1-4 of the study
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: each day of study
Blood pressure, pulse, and a Systematic Assessment For Treatment Emergent Events (SAFTEE) are collected daily. Electrocardiograms (EKGs) are collected at baseline and discharge.
each day of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Heather M Haughey, Ph.D., University of Virginia School of Medicine, Dept. Psychiatry and Neurobehavioral Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14392
  • R01DA027131 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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