Overview

Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana

Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine if the subjective effects of marijuana will be decreased by low-doses (< 25 mg) of naltrexone and increased by high-doses (> 50 mg) of naltrexone.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborators:
National Institute on Drug Abuse (NIDA)
Research Foundation for Mental Hygiene, Inc.
Treatments:
Naltrexone
Criteria
Inclusion Criteria:

- Current marijuana use

- Able to perform study procedures

- 21-45 years of age

- Women practicing an effective form of birth control

Exclusion Criteria:

- Current, repeated illicit drug use (other than marijuana)

- Presence of significant medical illness (e.g., diabetes, cardiovascular disease,
hypertension, examination, laboratory hepatitis, clinically significant laboratory
abnormalities, tests, 12-lead ECG, Mantoux test LFTs > 3x upper limit of normal)

- History of heart disease

- Request for drug treatment

- Current parole or probation

- Pregnancy or current lactation

- Recent history of significant violent behavior

- Previous adverse reaction to naltrexone

- Major current Axis I psychopathology Psychiatric interview (e.g., major depressive
disorder, bipolar disorder, suicide risk, schizophrenia)

- Current use of any prescription or over-the-counter medication