Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00373503
First received: September 7, 2006
Last updated: February 4, 2013
Last verified: February 2013

September 7, 2006
February 4, 2013
August 2005
June 2007   (final data collection date for primary outcome measure)
marijuana relapse [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Oral THC combined with lofexidine will result in the largest decrease in marijuana withdrawal symptoms and marijuana relapse compared to placebo.
  • Lofexidine will decrease a subset of marijuana withdrawal symptoms, e.g., muscle ache, chills, and will decrease marijuana relapse compared to placebo
  • Oral THC will decrease a subset of marijuana withdrawal symptoms, e.g., anxiety, marijuana craving, decreased food intake, and will decrease marijuana relapse compared to placebo
Complete list of historical versions of study NCT00373503 on ClinicalTrials.gov Archive Site
marijuana withdrawal symptoms [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Not Provided
cardiovascular effects [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Not Provided
 
Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse
Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse

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.

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 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. In mice, the α2-receptor agonist, clonidine, reversed symptoms of cannabinoid withdrawal (Lichtman et al., 2001). The purpose of this study is to determine if lofexidine, an α2-receptor agonist with a more favorable side-effect profile than clonidine, decreases symptoms of marijuana withdrawal and thus decreases marijuana relapse, as compared to placebo. Oral THC is FDA-approved for appetite enhancement. Lofexidine, which is currently not FDA-approved, is used in Europe to treat symptoms of heroin withdrawal, and to treat hypertension. For the purposes of this model, relapse is defined to a return to marijuana use after a period of abstinence. We have shown that oral THC reduces symptoms of marijuana withdrawal at doses that produce minimal intoxication (Haney et al., 2004). Thus, the effects of oral THC alone and in combination with lofexidine will be determined. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on each of four medication conditions for 8 days each: placebo, lofexidine, oral THC, and oral THC combined with lofexidine. During the inpatient study phases, participants will have the opportunity to self-administer placebo or active marijuana 6 times per day. Outpatient phases are for medication clearance so no medications will be administered. This study will provide important information of the effect of these potential treatment medications on both marijuana withdrawal symptoms, and on subsequent marijuana self-administration.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Marijuana Dependence
  • 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
Experimental: lofexidine, dronabinol, marijuana
lofexidine (.6 mg qid), dronabinol (20 mg tid)
Interventions:
  • Drug: Lofexidine
  • Drug: dronabinol
  • Drug: Marijuana
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
September 2008
June 2007   (final data collection date for primary outcome measure)

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
Both
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00373503
4942, R01DA019239
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Margaret Haney, Ph.D. New York State Psychiatric Institute
New York State Psychiatric Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP