Combined Pharmacotherapy for Cannabis Dependency (D-LUCS)
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ClinicalTrials.gov Identifier: NCT01020019 |
Recruitment Status
:
Completed
First Posted
: November 25, 2009
Results First Posted
: May 11, 2016
Last Update Posted
: April 6, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cannabis Dependence Marijuana Dependence | Drug: Dronabinol Drug: Placebo Drug: Lofexidine | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 156 participants |
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 |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |

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

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

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
United States, New York | |
New York State Psychiatric Institute | |
New York, New York, United States, 10032 |
Principal Investigator: | Frances R Levin, M.D. | Columbia University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Posted: | November 25, 2009 Key Record Dates |
Results First Posted: | May 11, 2016 |
Last Update Posted: | April 6, 2018 |
Last Verified: | March 2018 |
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 Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators 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 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 |