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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 24, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Frances R Levin, National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE November 24, 2009
First Posted Date  ICMJE November 25, 2009
Results First Submitted Date  ICMJE April 6, 2016
Results First Posted Date  ICMJE May 11, 2016
Last Update Posted Date April 24, 2019
Study Start Date  ICMJE January 2010
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
21 Days of Consecutive Abstinence as Measured by the Time-line Followback. [ Time Frame: reported daily for 12 weeks/ or study participation ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2009)
Reduction in self reported days of marijuana use as measured by the Time-line Followback. [ Time Frame: 12 weeks/ or study participation ]
Change History Complete list of historical versions of study NCT01020019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2009)
Marijuana withdrawal as measured by the MWC-10 item [ Time Frame: 12 weeks/ or study participation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Pharmacotherapy for Cannabis Dependency
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study of Lofexidine and Dronabinol for the Treatment of Marijuana Dependence
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cannabis Dependence
  • Marijuana Dependence
Intervention  ICMJE
  • Drug: Dronabinol
    Dronabinol: 20 mg/TID
    Other Name: Marinol
  • Drug: Placebo
    Placebo control
  • Drug: Lofexidine
    Lofex: .6 mg/ TID
Study Arms  ICMJE
  • Experimental: Lofexidine and Dronabinol
    Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
    Interventions:
    • Drug: Dronabinol
    • Drug: Lofexidine
  • Placebo Comparator: Placebo
    Lofex. matched placebo Dronabinol placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2015)
156
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2009)
180
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01020019
Other Study ID Numbers  ICMJE #6015
P50DA009236-16 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Frances R Levin, National Institute on Drug Abuse (NIDA)
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Frances R Levin, M.D. Columbia University
PRS Account New York State Psychiatric Institute
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP