Overview

Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate the interaction between marijuana and two potential treatment medications: lofexidine and oral THC, with the direct goal of using this information to improve marijuana treatment outcome.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Clonidine
Dronabinol
Lofexidine
Criteria
Inclusion Criteria:

- Current marijuana use: average of 3 marijuana cigarettes at least 4 times per week for
the past 4 weeks

- Able to perform study procedures

- 21-45 years of age

- Women practicing an effective form of birth control (condoms, diaphragm, birth control
pill, IUD)

Exclusion Criteria:

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

- Presence of significant medical illness (e.g., diabetes, cardiovascular disease,
hypertension, clinically significant laboratory abnormalities)

- Bradycardia (55 beats/minute), hypotension (< 90 mmHg) including orthostatic
hypotension (> 20 mmHg decrease in SP, or > 10 mmHg decrease in DP upon standing

- History of heart disease

- Request for drug treatment

- Current parole or probation

- Pregnancy or current lactation

- Recent history of significant violent behavior

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

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