Facilitating the Behavioral Treatment of Cannabis Use Disorder

Cannabis Dependence Clinical Trial

Official title:

Facilitating the Behavioral Treatment of Cannabis Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946489
• Other study ID #: 7355
• Secondary ID: K24DA029647
• Status: Completed
• Phase: Phase 1
• Start date: October 2016
• Est. completion date: August 2018

Study information

• Verified date: January 2020
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse

Intervention

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

Locations

Country	Name	City	State
United States	NYSPI	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At Week 6 (End of study)
Secondary	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.	Change between pre-infusion and end of 6 week study