Medications Development for the Treatment of Cannabis Related Disorders

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Virginia
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Analgesics; Aprepitant; Fosaprepitant; Molecular Mechanisms of Pharmacological Action; Nicotine; Peripheral Nervous System Agents

Criteria

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