Facilitating the Behavioral Treatment of Cannabis Use Disorder

NCT02946489 | Completed Phase 1 Results DMC

• 2 other identifiers: 7355K24DA029647
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Dependence

Keywords

cannabis; mindfulness based relapse prevention; motivational enhancement therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Confidence in Abstaining From Cannabis

  Change between pre-infusion and end of 6 week study

Study Arms (1)

CI-581a+MET+MBRP

EXPERIMENTAL

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

Interventions

CI-581a DRUG

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

CI-581a+MET+MBRP

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years of age
• Capacity to consent and comply with study procedures
• Seeking treatment

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

NYSPI

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Elias Dakwar, MD
• Organization: New York State Psychiatric Institute

elias.dakwar@nyspi.columbia.edu

6467748728

Study Officials

• Elias Dakwar, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Open label single-blind trial, with participants given the impression they may get any of several medications.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research psychiatrist

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 27, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 11, 2020
• Results First Posted: February 11, 2020

Record last verified: 2020-01

Locations

US (1)