search
Back to results

Facilitating the Behavioral Treatment of Cannabis Use Disorder

Primary Purpose

Cannabis Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CI-581a
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring cannabis, mindfulness based relapse prevention, motivational enhancement therapy

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NYSPI

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CI-581a+MET+MBRP

Arm 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

Outcomes

Primary Outcome Measures

Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use
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.

Secondary Outcome Measures

Confidence in Abstaining From Cannabis
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.

Full Information

First Posted
October 20, 2016
Last Updated
January 31, 2020
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT02946489
Brief Title
Facilitating the Behavioral Treatment of Cannabis Use Disorder
Official Title
Facilitating the Behavioral Treatment of Cannabis Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence
Keywords
cannabis, mindfulness based relapse prevention, motivational enhancement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Masking Description
Open label single-blind trial, with participants given the impression they may get any of several medications.
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CI-581a+MET+MBRP
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
CI-581a
Intervention Description
CI-581a will be administered in wk2 and potentially in wk 3 or 4.
Primary Outcome Measure Information:
Title
Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use
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)
Secondary Outcome Measure Information:
Title
Confidence in Abstaining From Cannabis
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elias Dakwar, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYSPI
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Facilitating the Behavioral Treatment of Cannabis Use Disorder

We'll reach out to this number within 24 hrs