Status:
COMPLETED
Medications Development for the Treatment of Cannabis Related Disorders
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Withdrawal
Marijuana Dependence
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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.
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 n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01204723
Start Date
August 1 2009
End Date
April 1 2012
Last Update
June 1 2012
Active Locations (2)
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1
Clinical Pharmacological Research Unit (CPRU), University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22903
2
University of Virginia Center for Addiction Education and Treatment (UVA CARE)
Charlottesville, Virginia, United States, 22908