Combined Pharmacotherapy for Cannabis Dependency (D-LUCS)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01020019

First Posted: November 25, 2009

Last Update Posted: June 17, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

New York State Psychiatric Institute

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: Dronabinol Drug: Placebo Drug: Lofexidine	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:

MedlinePlus related topics: Marijuana

Drug Information available for: Dronabinol

U.S. FDA Resources

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

Primary Outcome Measures:

21 Days of Consecutive Abstinence as Measured by the Time-line Followback. [ Time Frame: reported daily for 12 weeks/ or study participation ]


Enrollment:	156
Study Start Date:	January 2010
Study Completion Date:	September 2014
Primary Completion Date:	September 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: Dronabinol Dronabinol: 20 mg/TID Other Name: Marinol Drug: Lofexidine Lofex: .6 mg/ TID
Placebo Comparator: Placebo Lofex. matched placebo Dronabinol placebo	Drug: Placebo Placebo control

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women between the ages of 18-60 who meet DSM-IV criteria for current marijuana dependence
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.
Individual must describe marijuana as their primary drug of abuse.
Individuals must be capable of giving informed consent and capable of complying with study procedures.

Exclusion Criteria:

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.
Individuals who are medically unstable based on laboratory tests, electrocardiogram, medical history, physical examination that would make participation hazardous
Individuals with liver enzyme function tests greater than three times normal
Individuals with a history of seizure disorder
Individuals with current suicidal risk.
Individuals who are cognitively impaired
Bradycardia (< 50 beats/minute), hypotension (sitting or standing BP < 90/50), or symptoms attributable to low BP (i.e. lightheadedness or dizziness on standing).
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.
Individuals who are physiologically dependent on any other drugs (excluding nicotine) that would require a medical intervention
Individuals with known sensitivity to dronabinol or lofexidine
Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
Individuals currently being treated with an alpha-2 agonist antihypertensive medication
Individuals currently being prescribed a psychotropic medication (including sleep medication). However, medication for depression is allowed if stable for at least 1 month.
Individuals who have a job that even mild intoxication would be hazardous (e.g., firefighter, bus driver)
Individuals who are court-mandated to treatment.

Contacts and Locations

Information from the National Library of Medicine

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): NCT01020019

Locations


United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Frances R Levin, M.D.	Columbia University

More Information


Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT01020019 History of Changes
Other Study ID Numbers:	#6015 P50DA009236-16 ( U.S. NIH Grant/Contract )
First Submitted:	November 24, 2009
First Posted:	November 25, 2009
Results First Submitted:	April 6, 2016
Results First Posted:	May 11, 2016
Last Update Posted:	June 17, 2016
Last Verified:	May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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 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

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