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Facilitating the Behavioral Treatment of Cannabis Use Disorder

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ClinicalTrials.gov Identifier: NCT02946489
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

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 randomized, double-blind, controlled trial is to test various glutamate modulators in conjunction with motivational enhancement therapy (MET) and mindfulness based relapse prevention (MBRP) for cannabis use disorders.

Condition or disease Intervention/treatment Phase
Cannabis Dependence Drug: CI-581a Phase 2 Phase 3

Detailed Description:
Individuals diagnosed with cannabis dependence will be randomized to 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Masking Description: Single-blind trial, with participants given the impression they may get any of several medications.
Primary Purpose: Treatment
Official Title: Facilitating the Behavioral Treatment of Cannabis Use Disorder
Actual Study Start Date : October 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
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
Drug: CI-581a
CI-581a will be administered in wk2 and potentially in wk 3 or 4.




Primary Outcome Measures :
  1. Cannabis use by quantitative urine testing [ Time Frame: From baseline to week 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946489


Locations
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United States, New York
NYSPI
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Study Director: Frances R Levin, MD Columbia University
Principal Investigator: Elias Dakwar, MD Columbia University

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Responsible Party: Elias Dakwar, research psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02946489     History of Changes
Other Study ID Numbers: 7355
K24DA029647 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Keywords provided by Elias Dakwar, New York State Psychiatric Institute:
cannabis
mindfulness based relapse prevention
motivational enhancement therapy
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action