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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

Tracking Information
First Submitted Date  ICMJE October 20, 2016
First Posted Date  ICMJE October 27, 2016
Results First Submitted Date  ICMJE January 13, 2020
Results First Posted Date  ICMJE February 11, 2020
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use [ Time Frame: At Week 6 (End of study) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
Cannabis use by quantitative urine testing [ Time Frame: From baseline to week 6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
Confidence in Abstaining From Cannabis [ Time Frame: Change between pre-infusion and end of 6 week study ]
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Facilitating the Behavioral Treatment of Cannabis Use Disorder
Official Title  ICMJE Facilitating the Behavioral Treatment of Cannabis Use Disorder
Brief Summary Cannabis use disorders remain a significant public health problem. The pharmacological facilitation of behavioral treatment represents a promising strategy for addressing disordered cannabis use. Cannabis use disorders are recognized to be associated with various vulnerabilities that complicate the course of treatment and that may be amenable to glutamate modulators. The purpose of this single blind open-label trial is to test the feasibility of administering glutamate modulators in conjunction with motivational enhancement therapy (MET) and mindfulness based relapse prevention (MBRP) for cannabis use disorders.
Detailed Description Individuals diagnosed with cannabis dependence will receive one or two infusions of glutamate modulators during week 2 and week 3 or 4. The participants will also receive 2-week course of MET and 4-week course of MBRP. Participants will meet with staff twice weekly, except for week 2 and potentially week 3 or 4 during which participants will present to the clinic three times. Clinic visits include MET sessions, MBRP sessions, psychiatric monitoring, assessments, and study procedures (e.g., medication administration).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Masking Description:
Open label single-blind trial, with participants given the impression they may get any of several medications.
Primary Purpose: Treatment
Condition  ICMJE Cannabis Dependence
Intervention  ICMJE Drug: CI-581a
CI-581a will be administered in wk2 and potentially in wk 3 or 4.
Study Arms  ICMJE Experimental: CI-581a+MET+MBRP
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
Intervention: Drug: CI-581a
Publications * Not Provided

*   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: January 31, 2020)
8
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2016)
54
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meets DSM-IV criteria for cannabis dependence, with at least 5 days of use per week over the past 30 days and displaying at least one positive utox during screening
  • Physically healthy
  • No adverse reactions to study medications
  • 21-60 years of age
  • Capacity to consent and comply with study procedures
  • Seeking treatment

Exclusion Criteria:

  • Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance-induced psychosis, and current substance-induced mood disorder.
  • Physiological dependence on another substance requiring medical management, such as alcohol, opioids, or benzodiazepines, excluding caffeine, and nicotine.
  • Pregnant, interested in becoming pregnant, or lactating
  • Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
  • Current suicide risk or a history of suicide attempt within the past 2 years
  • On psychotropic or other medication whose effect could be disrupted by participation in the study
  • Recent history of significant violence (past 2 years).
  • Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
  • Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), anemia, pulmonary disease, active hepatitis or other liver disease (transaminase levels < 2-3 X the upper limit of normal will be considered acceptable), or untreated diabetes
  • Previous history of misuse of study medications
  • BMI > 35, or a history of undocumented obstructive sleep apnea
  • First degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis NOS)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 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 NCT02946489
Other Study ID Numbers  ICMJE 7355
K24DA029647 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elias Dakwar, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Elias Dakwar, MD Columbia University
PRS Account New York State Psychiatric Institute
Verification Date January 2020

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