Cannabis DependencePhase 1NCT02946489
Facilitating the Behavioral Treatment of Cannabis Use Disorder
A Phase 1 study testing CI-581a in people with Cannabis Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Cannabis Dependence
- What is being tested?
- CI-581a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Aug 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Cannabis Dependence
- Being tested
- CI-581a
- Keywords
- cannabis, mindfulness based relapse prevention, motivational enhancement therapy
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CI-581aDrug
CI-581a will be administered in wk2 and potentially in wk 3 or 4.
| Study group | Role | What they receive |
|---|---|---|
| CI-581a+MET+MBRP | Experimental | 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 Receives: Drug: CI-581a |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 6 (End of study)
Secondary outcomes (1)
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.
Measured: Change between pre-infusion and end of 6 week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cannabis DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Elias Dakwar, New York State Psychiatric Institute
- Investigators
- Elias Dakwar, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946489
- Sponsor's protocol ID
- 7355
- Other IDs
- K24DA029647
- Status last verified
- Jan 2020
- First submitted
- 20 Oct 2016
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating the Behavioral Treatment of Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT02946489
- Acronym / sponsor ID
- 7355
- Conditions
- Cannabis Dependence
- Keywords
- cannabis, mindfulness based relapse prevention, motivational enhancement therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Posted 11 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CI-581a+MET+MBRP | Experimental | Drug: CI-581aAdministration 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 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CI-581aCI-581a will be administered in wk2 and potentially in wk 3 or 4. | Drug | CI-581a+MET+MBRP |
Primary outcome
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.
1 secondary outcome
Confidence in Abstaining From Cannabis
Time frame: Change between pre-infusion and end of 6 week study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elias Dakwar, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CI-581a in people with Cannabis Dependence, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use (time frame: At Week 6 (End of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.