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Combined Pharmacotherapy for Cannabis Dependency (D-LUCS)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01020019
First received: November 24, 2009
Last updated: May 16, 2016
Last verified: May 2016
Results First Received: April 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cannabis Dependence
Marijuana Dependence
Interventions: Drug: Dronabinol
Drug: Placebo
Drug: Lofexidine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were treated at the Substance Treatment and Research Service (STARS) of Columbia University/ New York State Psychiatric Institute (NYSPI). Study enrollment occurred from January 2010 through May 2014 with study completion in September 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study included a one-week placebo lead-in phase. Participants were randomized at the end of the placebo lead-in phase and those who reported marijuana use less than once a week during the lead-in phase were considered placebo responders and were not randomized. A total of 34 participants discontinued prior to randomization for various reasons.

Reporting Groups
  Description
Placebo

Lofex. matched placebo Dronabinol placebo

Placebo: Placebo control

Lofexidine and Dronabinol

Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol

Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID


Participant Flow:   Overall Study
    Placebo     Lofexidine and Dronabinol  
STARTED     61     61  
COMPLETED     35     32  
NOT COMPLETED     26     29  
Lost to Follow-up                 21                 18  
Adverse Event                 1                 5  
not interested in treatment                 4                 4  
moving                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

Lofex. matched placebo Dronabinol placebo

Placebo: Placebo control

Lofexidine and Dronabinol

Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol

Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID

Total Total of all reporting groups

Baseline Measures
    Placebo     Lofexidine and Dronabinol     Total  
Number of Participants  
[units: participants]
  61     61     122  
Age  
[units: years]
Mean (Standard Deviation)
  35.4  (10.8)     34.8  (11.2)     35.2  (10.9)  
Gender  
[units: participants]
     
Female     16     22     38  
Male     45     39     84  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic     15     17     32  
Black     17     18     35  
White     26     21     47  
Other     3     5     8  



  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Daniel Brooks
Organization: New York State Psychiatric Institute
phone: 646-774-6171
e-mail: brooksd@nyspi.columbia.edu



Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01020019     History of Changes
Other Study ID Numbers: #6015
P50DA009236-16 ( US NIH Grant/Contract Award Number )
Study First Received: November 24, 2009
Results First Received: April 6, 2016
Last Updated: May 16, 2016
Health Authority: United States: Food and Drug Administration