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OpenTrials
Completed

NCT Number: NCT02946489

Facilitating the Behavioral Treatment of Cannabis Use Disorder

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NYSPI

New York, 10032, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CI-581a

Drug

CI-581a will be administered in wk2 and potentially in wk 3 or 4.

Primary outcomes

  1. Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use

    Time frame: 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 outcomes

  1. Confidence in Abstaining From Cannabis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2016
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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