Status:
COMPLETED
Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Marijuana Dependence
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
Brief 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 improv...
Detailed Description
Only a small percentage of dependent-marijuana smokers who are seeking treatment for their marijuana use is able to achieve sustained abstinence. The objective of this study is to investigate the inte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00373503
Start Date
August 1 2005
End Date
September 1 2008
Last Update
February 5 2013
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032