Clinical trial NCT02946489: Facilitating the Behavioral Treatment of Cannabis Use Disorder
Official title: Facilitating the Behavioral Treatment of Cannabis Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cannabis Dependence
Keywords: cannabis
mindfulness based relapse prevention
motivational enhancement therapy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-10-27
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use
timeFrame: At Week 6 (End of study)
Secondary outcomes:
measure: Confidence in Abstaining From Cannabis
timeFrame: Change between pre-infusion and end of 6 week study
Other outcomes:
Locations:
city: New York
country: United States
facility: NYSPI
state: New York
Study officials:
affiliation: Columbia University
name: Elias Dakwar, MD
role: PRINCIPAL_INVESTIGATOR
References: