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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)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cannabis Dependence
Marijuana Dependence
Interventions Drug: Dronabinol
Drug: Placebo
Drug: Lofexidine
Enrollment 156
Recruitment Details 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 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.
Arm/Group Title Placebo Lofexidine and Dronabinol
Hide Arm/Group Description

Lofex. matched placebo Dronabinol placebo

Placebo: Placebo control

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

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

Period Title: Overall Study
Started 61 61
Completed 35 32
Not Completed 26 29
Reason Not Completed
Lost to Follow-up             21             18
Adverse Event             1             5
not interested in treatment             4             4
moving             0             2
Arm/Group Title Placebo Lofexidine and Dronabinol Total
Hide Arm/Group Description

Lofex. matched placebo Dronabinol placebo

Placebo: Placebo control

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

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

Total of all reporting groups
Overall Number of Baseline Participants 61 61 122
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 61 participants 122 participants
35.4  (10.8) 34.8  (11.2) 35.2  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
Female
16
  26.2%
22
  36.1%
38
  31.1%
Male
45
  73.8%
39
  63.9%
84
  68.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
Hispanic 15 17 32
Black 17 18 35
White 26 21 47
Other 3 5 8
1.Primary Outcome
Title 21 Days of Consecutive Abstinence as Measured by the Time-line Followback.
Hide Description [Not Specified]
Time Frame reported daily for 12 weeks/ or study participation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Lofexidine and Dronabinol
Hide Arm/Group Description:

Lofex. matched placebo Dronabinol placebo

Placebo: Placebo control

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

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

Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: participants
18 17
Time Frame 12 weeks of trial or participants length of participation
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Lofexidine and Dronabinol
Hide Arm/Group Description

Lofex. matched placebo Dronabinol placebo

Placebo: Placebo control

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

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

All-Cause Mortality
Placebo Lofexidine and Dronabinol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Lofexidine and Dronabinol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/61 (1.64%)      1/61 (1.64%)    
Gastrointestinal disorders     
abdominal pain   0/61 (0.00%)  0 1/61 (1.64%)  1
Psychiatric disorders     
detoxification   1/61 (1.64%)  1 0/61 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Lofexidine and Dronabinol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/61 (75.41%)      47/61 (77.05%)    
Gastrointestinal disorders     
nausea   5/61 (8.20%)  5 6/61 (9.84%)  6
stomache upset   5/61 (8.20%)  5 2/61 (3.28%)  2
diarrhea   4/61 (6.56%)  4 2/61 (3.28%)  2
vomitting   4/61 (6.56%)  4 2/61 (3.28%)  2
gas   1/61 (1.64%)  1 3/61 (4.92%)  3
General disorders     
dry mouth   6/61 (9.84%)  6 27/61 (44.26%)  27
fatigue   15/61 (24.59%)  15 26/61 (42.62%)  26
dizzy   12/61 (19.67%)  12 21/61 (34.43%)  21
insomnia   13/61 (21.31%)  13 13/61 (21.31%)  13
intoxication   2/61 (3.28%)  2 13/61 (21.31%)  13
headache   12/61 (19.67%)  12 10/61 (16.39%)  10
drowsiness   4/61 (6.56%)  4 9/61 (14.75%)  9
irritability   6/61 (9.84%)  6 3/61 (4.92%)  3
fever   4/61 (6.56%)  4 1/61 (1.64%)  1
sore throat   3/61 (4.92%)  3 2/61 (3.28%)  2
Metabolism and nutrition disorders     
decreased appetite   6/61 (9.84%)  6 2/61 (3.28%)  2
Nervous system disorders     
confusion   1/61 (1.64%)  1 3/61 (4.92%)  3
Psychiatric disorders     
anxiety   11/61 (18.03%)  11 3/61 (4.92%)  3
depression   5/61 (8.20%)  5 3/61 (4.92%)  3
Respiratory, thoracic and mediastinal disorders     
upper respiratory infection   8/61 (13.11%)  8 2/61 (3.28%)  2
Skin and subcutaneous tissue disorders     
sweating   5/61 (8.20%)  5 5/61 (8.20%)  5
rash   3/61 (4.92%)  3 0/61 (0.00%)  0
Vascular disorders     
hypotension   1/61 (1.64%)  1 10/61 (16.39%)  10
orthostasis   1/61 (1.64%)  1 4/61 (6.56%)  4
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel Brooks
Organization: New York State Psychiatric Institute
Phone: 646-774-6171
EMail: brooksd@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: Frances R Levin, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01020019     History of Changes
Other Study ID Numbers: #6015
P50DA009236-16 ( U.S. NIH Grant/Contract )
First Submitted: November 24, 2009
First Posted: November 25, 2009
Results First Submitted: April 6, 2016
Results First Posted: May 11, 2016
Last Update Posted: April 24, 2019