Cannabis Dependence
Conditions
Keywords
cannabis, mindfulness based relapse prevention, motivational enhancement therapy
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).
Interventions
DRUGCI-581a
CI-581a will be administered in wk2 and potentially in wk 3 or 4.
Sponsors
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Open label single-blind trial, with participants given the impression they may get any of several medications.
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CI-581a+MET+MBRP 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
CI-581a: CI-581a will be administered in wk2 and potentially in wk 3 or 4. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | CI-581a+MET+MBRP |
|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
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.
Time frame: At Week 6 (End of study)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CI-581a+MET+MBRP | Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use | 7 Participants |
Secondary
Confidence in Abstaining From Cannabis
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.
Time frame: Change between pre-infusion and end of 6 week study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CI-581a+MET+MBRP | Confidence in Abstaining From Cannabis | 42.8125 units on a scale | Standard Deviation 27.56283 |