Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Facilitating the Behavioral Treatment of Cannabis Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946489
Recruitment Status : Completed
First Posted : October 27, 2016
Results First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Cannabis Dependence
Intervention Drug: CI-581a
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CI-581a+MET+MBRP
Hide Arm/Group Description

Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP

CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4.

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title CI-581a+MET+MBRP
Hide Arm/Group Description

Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP

CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4.

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
42.5  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female 4
Male 4
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
4
  50.0%
Not Hispanic or Latino
4
  50.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  37.5%
White
4
  50.0%
More than one race
1
  12.5%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use
Hide Description Percentage of participants with cannabis abstinence or significant reduction in cannabis use by end of study. Significant reduction in cannabis use was defined as: At least 50% reduction in cannabis use between pre-infusion and end of 6 week study.
Time Frame At Week 6 (End of study)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CI-581a+MET+MBRP
Hide Arm/Group Description:

Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP

CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4.

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
7
  87.5%
2.Secondary Outcome
Title Confidence in Abstaining From Cannabis
Hide Description Change in confidence in abstaining from cannabis as measured by the DCQ (Drug-Taking Confidence Questionnaire). DCQ is a scale from 0 to 100, with higher values indicating greater confidence in one's ability to abstain from cannabis.
Time Frame Change between pre-infusion and end of 6 week study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CI-581a+MET+MBRP
Hide Arm/Group Description:

Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP

CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
42.8125  (27.56283)
Time Frame Adverse event data were collected throughout the study period (6 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CI-581a+MET+MBRP
Hide Arm/Group Description

Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP

CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4.

All-Cause Mortality
CI-581a+MET+MBRP
Affected / at Risk (%)
Total   0/8 (0.00%) 
Hide Serious Adverse Events
CI-581a+MET+MBRP
Affected / at Risk (%)
Total   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CI-581a+MET+MBRP
Affected / at Risk (%)
Total   0/8 (0.00%) 
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: Elias Dakwar, MD
Organization: New York State Psychiatric Institute
Phone: 6467748728
EMail: elias.dakwar@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: Elias Dakwar, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02946489    
Other Study ID Numbers: 7355
K24DA029647 ( U.S. NIH Grant/Contract )
First Submitted: October 20, 2016
First Posted: October 27, 2016
Results First Submitted: January 13, 2020
Results First Posted: February 11, 2020
Last Update Posted: February 11, 2020