Facilitating the Behavioral Treatment of Cannabis Use Disorder
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 60 |
| Updated: | 1/16/2019 |
| Start Date: | October 2016 |
| End Date: | August 2018 |
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 randomized, double-blind, controlled trial is to test various
glutamate modulators in conjunction with motivational enhancement therapy (MET) and
mindfulness based relapse prevention (MBRP) for cannabis use disorders.
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 randomized, double-blind, controlled trial is to test various
glutamate modulators in conjunction with motivational enhancement therapy (MET) and
mindfulness based relapse prevention (MBRP) for cannabis use disorders.
Individuals diagnosed with cannabis dependence will be randomized to 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).
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).
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)
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