Facilitating the Behavioral Treatment of Cannabis Use Disorder

Phase 1

Completed

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).

Recruitment & 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)

Arm && Interventions

Group	Intervention	Description
CI-581a+MET+MBRP	CI-581a	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.