- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01020019
Combined Pharmacotherapy for Cannabis Dependency (D-LUCS)
April 22, 2019 updated by: Frances R Levin, New York State Psychiatric Institute
A Randomized, Double-Blind, Placebo-Controlled Study of Lofexidine and Dronabinol for the Treatment of Marijuana Dependence
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
156
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lofexidine and Dronabinol
Maintained at 1.8mg/day Lofex.
and 60 mg/day of Dronabinol
|
Dronabinol: 20 mg/TID
Other Names:
Lofex: .6 mg/ TID
|
Placebo Comparator: Placebo
Lofex.
matched placebo Dronabinol placebo
|
Placebo control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
21 Days of Consecutive Abstinence as Measured by the Time-line Followback.
Time Frame: reported daily for 12 weeks/ or study participation
|
reported daily for 12 weeks/ or study participation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Frances R Levin, M.D., Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
November 24, 2009
First Submitted That Met QC Criteria
November 24, 2009
First Posted (Estimate)
November 25, 2009
Study Record Updates
Last Update Posted (Actual)
April 24, 2019
Last Update Submitted That Met QC Criteria
April 22, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Marijuana Abuse
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Psychotropic Drugs
- Narcotic Antagonists
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
- Lofexidine
Other Study ID Numbers
- #6015
- P50DA009236-16 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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