Combined Pharmacotherapy for Cannabis Dependency
D-LUCS
A Randomized, Double-Blind, Placebo-Controlled Study of Lofexidine and Dronabinol for the Treatment of Marijuana Dependence
2 other identifiers
interventional
156
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
May 11, 2016
CompletedApril 24, 2019
April 1, 2019
4.7 years
November 24, 2009
April 6, 2016
April 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
21 Days of Consecutive Abstinence as Measured by the Time-line Followback.
reported daily for 12 weeks/ or study participation
Study Arms (2)
Lofexidine and Dronabinol
EXPERIMENTALMaintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Placebo
PLACEBO COMPARATORLofex. matched placebo Dronabinol placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (1)
Brezing CA, Choi CJ, Pavlicova M, Brooks D, Mahony AL, Mariani JJ, Levin FR. Abstinence and reduced frequency of use are associated with improvements in quality of life among treatment-seekers with cannabis use disorder. Am J Addict. 2018 Mar;27(2):101-107. doi: 10.1111/ajad.12660. Epub 2018 Feb 19.
PMID: 29457671DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel Brooks
- Organization
- New York State Psychiatric Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Frances R Levin, M.D.
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Substance Use Disorder
Study Record Dates
First Submitted
November 24, 2009
First Posted
November 25, 2009
Study Start
January 1, 2010
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
April 24, 2019
Results First Posted
May 11, 2016
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share