Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse
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ClinicalTrials.gov Identifier: NCT00373503 |
Recruitment Status
:
Completed
First Posted
: September 8, 2006
Last Update Posted
: February 5, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Marijuana Dependence | Drug: Lofexidine Drug: dronabinol Drug: Marijuana | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse |
Study Start Date : | August 2005 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: lofexidine, dronabinol, marijuana
lofexidine (.6 mg qid), dronabinol (20 mg tid)
|
Drug: Lofexidine
alpha 2 adrenergic agonist, hypothesized to decrease noradrenergic activity
Other Name: Britlofex
Drug: dronabinol
cannabinoid agonist hypothesized to decrease MJ withdrawal
Other Name: THC
Drug: Marijuana
marijuana intoxication, withdrawal and relapse assessed
Other Name: cannabis
|
- marijuana relapse [ Time Frame: 4 days ]
- marijuana withdrawal symptoms [ Time Frame: 3 days ]
- cardiovascular effects [ Time Frame: 7 days ]

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Ages Eligible for Study: | 21 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373503
United States, New York | |
New York State Psychiatric Institute | |
New York, New York, United States, 10032 |
Principal Investigator: | Margaret Haney, Ph.D. | New York State Psychiatric Institute |
Responsible Party: | New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT00373503 History of Changes |
Other Study ID Numbers: |
4942 R01DA019239 ( U.S. NIH Grant/Contract ) |
First Posted: | September 8, 2006 Key Record Dates |
Last Update Posted: | February 5, 2013 |
Last Verified: | February 2013 |
Keywords provided by New York State Psychiatric Institute:
Lofexidine Oral THC Cannabinoids |
Additional relevant MeSH terms:
Marijuana Abuse Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Dronabinol Clonidine Lofexidine Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antihypertensive Agents Narcotic Antagonists Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Sympatholytics Autonomic Agents |