Medications Development for the Treatment of Cannabis Related Disorders

Completed · Phase 1 · Has a placebo group

Conditions studied: Nicotine Withdrawal, Marijuana Dependence, Cannabis Dependence, Nicotine Dependence, Cannabis Abuse

In brief

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.

Key facts

Study ID

NCT01204723

Run by

University of Virginia

People needed

63

Starts

2009-08-01

Expected to finish

2012-04-01

Last updated by the study team

2012-06-01

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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
• 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

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

Where it is running

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

Full record on ClinicalTrials.gov

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