Combined Pharmacotherapy for Cannabis Dependency (D-LUCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01020019
First received: November 24, 2009
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to see if Lofexidine in combination with Marinol is superior to placebo in achieving abstinence, reducing cannabis use and reducing withdrawal in cannabis-dependent patients seeking treatment for their marijuana use.


Condition Intervention Phase
Cannabis Dependence
Marijuana Dependence
Drug: Lofexidine and Dronabinol
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Lofexidine and Dronabinol for the Treatment of Marijuana Dependence

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Reduction in self reported days of marijuana use as measured by the Time-line Followback. [ Time Frame: reported daily for 12 weeks/ or study participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Marijuana withdrawal as measured by the MWC-10 item [ Time Frame: reported 2x/week for 12 weeks/ or study participation ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lofexidine and Dronabinol
Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Drug: Lofexidine and Dronabinol
Lofex: .6 mg/ TID Dronabinol: 20 mg/TID
Other Name: Marinol
Placebo Comparator: Placebo
Lofex. matched placebo Dronabinol placebo
Drug: Placebo
Placebo control
Other Name: Placebo

Detailed Description:

Cannabis use disorders remain the most common illicit drug use disorder and options for treatment remain limited. Compared to other abusable substances, there has been little investigation of pharmacotherapies for cannabis dependence and no effective pharmacotherapy for cannabis dependence has yet to been developed. The development of effective cannabis dependence pharmacotherapy is an important unmet public health need. Agonist pharmacotherapy strategies have been effective for other substance use disorders (e.g., opioid and nicotine use disorders) and the endocannabinoid system represents a promising target for agonist pharmacotherapy with dronabinol. Lofexidine, a noradrenergic system suppressant, is effective in treating opioid withdrawal and shows promise as a cannabis use disorder pharmacotherapy. Haney et al. (2008) found that the combination of lofexidine and dronabinol (Lofex-Dro) was superior to placebo, lofexidine alone, or dronabinol alone in improving sleep and other cannabis withdrawal symptoms. Further, reduction in craving and relapse was greater for this combined pharmacotherapy relative to either medication alone or placebo. The proposed protocol is a 2 group, double blind, placebo-controlled outpatient study of the safety and efficacy of the combination of dronabinol and lofexidine for the treatment of cannabis dependence. We plan to enroll 180 subjects in a 12-week trial. The primary hypothesis is that dronabinol will act as an agonist treatment while lofexidine will suppress craving- and cue-induced related stress such that the combination will act in a complementary manner to induce prolonged abstinence from marijuana.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women between the ages of 18-60 who meet DSM-IV criteria for current marijuana dependence
  2. Individuals must report using marijuana at least 5 days a week and have a positive urine test for THC on the day of study entry.
  3. Individual must describe marijuana as their primary drug of abuse.
  4. Individuals must be capable of giving informed consent and capable of complying with study procedures.

Exclusion Criteria:

  1. Meets DSM-IV-TR criteria for schizophrenia, schizoaffective illness, psychotic disorder other than transient psychosis due to drug abuse, major depression, bipolar illness or psychiatric disorders (other than substance abuse) which require psychiatric intervention.
  2. Individuals who are medically unstable based on laboratory tests, electrocardiogram, medical history, physical examination that would make participation hazardous
  3. Individuals with liver enzyme function tests greater than three times normal
  4. Individuals with a history of seizure disorder
  5. Individuals with current suicidal risk.
  6. Individuals who are cognitively impaired
  7. Bradycardia (< 50 beats/minute), hypotension (sitting or standing BP < 90/50), or symptoms attributable to low BP (i.e. lightheadedness or dizziness on standing).
  8. Nursing mothers and pregnant women. Women of child bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, urine pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.
  9. Individuals who are physiologically dependent on any other drugs (excluding nicotine) that would require a medical intervention
  10. Individuals with known sensitivity to dronabinol or lofexidine
  11. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
  12. Individuals currently being treated with an alpha-2 agonist antihypertensive medication
  13. Individuals currently being prescribed a psychotropic medication (including sleep medication). However, medication for depression is allowed if stable for at least 1 month.
  14. Individuals who have a job that even mild intoxication would be hazardous (e.g., firefighter, bus driver)
  15. Individuals who are court-mandated to treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020019

Contacts
Contact: Amy Mahony, MA (212) 740-7350 mahonya@pi.cpmc.columbia.edu
Contact: Daniel J Brooks, MA (212) 740-3205 brooksd@pi.cpmc.columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Amy Mahony, M.A.    212-923-3031    mahonya@pi.cpmc.columbia.edu   
Contact: Elizabeth Martinez    (212) 923-3031    martinez@pi.cpmc.columbia.edu   
Principal Investigator: Frances R Levin, M.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Frances R Levin, M.D. Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01020019     History of Changes
Other Study ID Numbers: #6015, P50DA009236-16, DPMC
Study First Received: November 24, 2009
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
Cannabis Dependence
Marijuana Dependence
Marinol
Lofexidine

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Lofexidine
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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
Cardiovascular Agents
Narcotic Antagonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on August 20, 2014