Phase 1
N=8
Facilitating the Behavioral Treatment of Cannabis Use Disorder
Cannabis Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02946489 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- CI-581a (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use |
7 | — |
| SECONDARY Confidence in Abstaining From Cannabis |
42.8125 | — |
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.
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 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)
Data sourced from ClinicalTrials.gov (NCT02946489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.