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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 : November 1, 2018
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
Name/Title: Daniel Brooks
Organization: New York State Psychiatric Institute
Phone: 646-774-6171
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: November 1, 2018