Facilitating the Behavioral Treatment of Cannabis Use Disorder

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02946489
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 22
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Dependence	Drug: CI-581a	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• 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
• Official Title: Facilitating the Behavioral Treatment of Cannabis Use Disorder
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Confidence in Abstaining From Cannabis [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYSPI	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Elias Dakwar, MD, Columbia University

Study Documents (Full-Text)

• Study Protocol - May 30, 2018

More Information

Publications

None provided.

• Responsible Party: Elias Dakwar, research psychiatrist, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT02946489
• Other Study ID Numbers: 7355; K24DA029647
• First Posted: Oct 27, 2016
• Last Update Posted: Feb 11, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Elias Dakwar, research psychiatrist, New York State Psychiatric Institute: cannabis; mindfulness based relapse prevention; motivational enhancement therapy
• Additional relevant MeSH terms: Marijuana Abuse; Ketamine

Study Results

Participant Flow

Arm/Group Title	CI-581a+MET+MBRP
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

Baseline Characteristics

Arm/Group Title	CI-581a+MET+MBRP
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 Participants	8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.5 (13.5)
Sex: Female, Male (Count of Participants)
Female	4 50%
Male	4 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 50%
Not Hispanic or Latino	4 50%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 37.5%
White	4 50%
More than one race	1 12.5%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CI-581a+MET+MBRP
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.
Measure Participants	8
Count of Participants [Participants]	7 87.5%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CI-581a+MET+MBRP
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.
Measure Participants	8
Mean (Standard Deviation) [units on a scale]	42.8125 (27.56283)

Adverse Events

Time Frame	Adverse event data were collected throughout the study period (6 weeks)
Arm/Group Title	CI-581a+MET+MBRP
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 (%)	# Events
Total	0/8 (0%)
Serious Adverse Events
	CI-581a+MET+MBRP
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	CI-581a+MET+MBRP
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.