Medications Development for the Treatment of Cannabis Related Disorders
MTC
2 other identifiers
interventional
63
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2009
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 14, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJune 1, 2012
May 1, 2012
2.4 years
September 14, 2010
May 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
withdrawal symptom severity, measured on a 0 (not at all) to 3 (severe) scale
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
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
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 Outcomes (3)
sleep quality
collected on each study day
Neurocognitive Function
collected on days 1-4 of the study
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
each day of study
Study Arms (3)
Behavioral Condition 1
EXPERIMENTALNicotine patch (21 mg) plus placebo oral cannabis (0 mg; 3 times a day on days 2-4, given once on day 5)
Behavioral Condition 2
EXPERIMENTALPlacebo nicotine patch (0 mg) plus oral cannabis (10 mg, 3 times each day, days 2-4, day 5 given once)
Behavioral Condition 3
EXPERIMENTALPlacebo nicotine patch (0 mg) plus placebo oral cannabis (0 mg, 3 times each day days 2-4, day 5 given once)
Interventions
Placebo Aprepitant 0 mg once daily for 5 days
Active Aprepitant 160 mg once daily for 5 days
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
Clinical Pharmacological Research Unit (CPRU), University of Virginia School of Medicine
Charlottesville, Virginia, 22903, United States
University of Virginia Center for Addiction Education and Treatment (UVA CARE)
Charlottesville, Virginia, 22908, United States
Related Publications (1)
Gunderson EW, Haughey HM, Ait-Daoud N, Joshi AS, Hart CL. A survey of synthetic cannabinoid consumption by current cannabis users. Subst Abus. 2014;35(2):184-9. doi: 10.1080/08897077.2013.846288.
PMID: 24821356DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather M Haughey, Ph.D.
University of Virginia School of Medicine, Dept. Psychiatry and Neurobehavioral Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2010
First Posted
September 17, 2010
Study Start
August 1, 2009
Primary Completion
January 1, 2012
Study Completion
April 1, 2012
Last Updated
June 1, 2012
Record last verified: 2012-05