Verified October 2016 by New York State Psychiatric Institute
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT02946489
First received: October 20, 2016
Last updated: October 25, 2016
Last verified: October 2016
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.
| Cannabis Dependence | Drug: CI-581a Drug: CI-581b Behavioral: Motivational Enhancement Therapy (MET) Behavioral: Mindfulness Based Relapse Prevention |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Facilitating the Behavioral Treatment of Cannabis Use Disorder |
- Cannabis use by quantitative urine testing [ Time Frame: From baseline to week 6 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 54 |
| Study Start Date: | October 2016 |
| Estimated Study Completion Date: | October 2018 |
| Estimated Primary Completion Date: | October 2018 (Final data collection date for primary outcome measure) |
| Experimental: 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 |
Drug: CI-581a
CI-581a will be administered in wk2 and potentially in wk 3 or 4. Behavioral: Motivational Enhancement Therapy (MET) The participants will engage in MET in the first two weeks of trial Behavioral: Mindfulness Based Relapse Prevention The participants will engage in MBRP in weeks 3 to 6. |
| Active Comparator: CI-581B+MET+MBRP
Administration of CI-581b 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 |
Drug: CI-581b
CI-581b will be administered in wk2 and potentially in wk 3 or 4. Behavioral: Motivational Enhancement Therapy (MET) The participants will engage in MET in the first two weeks of trial Behavioral: Mindfulness Based Relapse Prevention The participants will engage in MBRP in weeks 3 to 6. |
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).
| Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT02946489
| NYSPI | |
| NY, New York, United States, 10032 | |
| Contact: Rozita Alaluf 646-774-6170 | |
| Principal Investigator: Elias Dakwar, MD | |
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
| Study Director: | Frances R Levin, MD | Columbia University |
| Principal Investigator: | Elias Dakwar, MD | Columbia University |
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT02946489 History of Changes |
| Other Study ID Numbers: | 7355 K24DA029647 |
| Study First Received: | October 20, 2016 |
| Last Updated: | October 25, 2016 |
| Health Authority: | United States: Food and Drug Administration United States: Data and Safety Monitoring Board United States: Institutional Review Board |
Keywords provided by New York State Psychiatric Institute:
| cannabis mindfulness based relapse prevention motivational enhancement therapy |
Additional relevant MeSH terms:
| Marijuana Abuse Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 27, 2016