Alcohol Use DisorderPhase 2NCT04084860
The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking
A Phase 2 study testing CI-581a, CI-581b and MBRP in people with Alcohol Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The proposed project tests the efficacy of glutamate modulators in non-depressed individuals with alcohol use disorder (AUD); the primary hypothesis is that the glutamate modulator being tested reduces heavy drinking days compared to the active control. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- CI-581a, CI-581b and MBRP
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2019to 31 Aug 2024
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active alcohol use disorder, with at least 4 heavy drinking day over the past 7 days (greater than 4 drinks a day for males, greater than 3 drinks for females). In the case of the use of other drugs, alcohol is designated as the primary drug
- Physically healthy
- No adverse reactions to study medications
- 21-70 years of age
- Capacity to consent and comply with study procedures, including sufficient proficiency in English
- Seeking to reduce or stop alcohol use
Who cannot join
- Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, or any psychotic illness, including substance-induced psychosis
- Physiological dependence on another substance, such as opioids or benzodiazepines, excluding caffeine, nicotine, and cannabis
- Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
- Current suicide risk or a history of suicide attempt within the past year
- Inability to safely initiate 24 hours of abstinence from alcohol, as evidenced by CIWA greater than 10 during screening; history of severe withdrawal phenomena over the past 6 months (e.g., inpatient stabilization, withdrawal-related seizure); or self-reported inability to maintain abstinence for 24 hours.
- Pregnant or interested in becoming pregnant during the study period
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- Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
- Unstable physical disorders which might make participation hazardous such as hypertension (>160/90), anemia, active hepatitis or other liver disease (transaminase levels < 2-3 X the upper limit of normal will be considered acceptable), epilepsy, or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that study medications in combination with this medication may increase the risk of drug-induced hepatitis.
- Previous history of misuse or abuse of study medications, and a history of an adverse reaction/experience with prior exposure to study medications
- Recent history of significant violance
- On psychotropic or other medications whose effect could be disrupted by participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elias Dakwar, MD contact
United States1 site, 1 recruiting
- Recruiting
NYSPI
New York, New York, 10032
H.O.P.E. Clinic, 888-497-8427
Elias Dakwar, MD
About this study
Official title: The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking: a Randomized, Controlled Trial
The proposed project tests the efficacy of glutamate modulators in non-depressed individuals with alcohol use disorder (AUD); the primary hypothesis is that the glutamate modulator being tested reduces heavy drinking days compared to the active control. It also aims to investigate, using a 2 by 2 factorial (2x2) design, the hypothesis that the effects of the glutamate modulator are enhanced when combined with behavioral treatment.
Read the detailed description
Alterations in glutamate neurotransmission are an important target of pharmacotherapy for alcohol use disorder. Our investigations with glutamate modulators in drug and alcohol dependent individuals suggest that they may exert unique therapeutic effects on dependence-related vulnerabilities and may also address problem drinking in alcohol dependent individuals. The proposed project will expand on our prior research by testing the efficacy of glutamate modulators in a larger population of non-depressed individuals with alcohol use disorder (AUD); it also aims to investigate, using a 2 by 2 factorial (2x2) design, the hypothesis that the effects of the glutamate modulator are enhanced when combined with behavioral treatment. It, therefore, has the potential to deepen our understanding of the therapeutic role of glutamate modulators in AUD treatment, as well as to provide further evidence for the efficacy of this novel pharmacotherapy strategy in addressing problem use
- Conditions
- Alcohol Use Disorder
- Being tested
- CI-581a, CI-581b, MBRP, MET
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CI-581aDrug
CI-581a during weeks 1 and 6 at 0.71 mg/kg
CI-581bDrug
CI-581b during weeks 1 and 6 at 0.0125 mg/kg
MBRPBehavioural
Also called Mindfulness Based Relapse Prevention (MBRP)
MBRP will help with maintaining use reduction/abstinence.In this trial, 3 sessions will occur in the first 2 weeks following the second infusion (weeks 6 and 7), while one session a week will be administered in the latter 5 weeks (weeks 8 through 12).
METBehavioural
Also called Motivational Enhancement Therapy (MET)
MET may help with goal setting and enhancing engagement with MBRP. In this trial, a standard 5-week MET platform will be provided to individuals randomized to receive behavioral treatment, with an additional session after each infusion (7 sessions total).
| Study group | Role | What they receive |
|---|---|---|
| CI-581a + MET/MBRP | Experimental | Administration of CI-581a during weeks 1 and 6 at 0.71 mg/kg in the context of a 12 wk outpatient treatment (behavioral treatment combination of MET/MBRP will be provided) Receives: Drug: CI-581a; Behavioral: MBRP; Behavioral: MET |
| CI-581a + Medication Management | Experimental | Administration of CI-581a during weeks 1 and 6 at 0.71 mg/kg in the context of a 12 wk outpatient treatment ( no MET/MBRP sessions will be provided, only general check-ins and psychiatrist visits) Receives: Drug: CI-581a |
| CI-581b + MET/MBRP | Active comparator | Administration of CI-581b during weeks 1 and 6 at 0.0125 mg/kg in the context of a 12 wk outpatient treatment (behavioral treatment combination of MET/MBRP will be provided) Receives: Drug: CI-581b; Behavioral: MBRP; Behavioral: MET |
| CI-581b + Medication Management | Active comparator | Administration of CI-581b during weeks 1 and 6 at 0.0125 mg/kg in the context of a 12 wk outpatient treatment (no MET/MBRP sessions will be provided, only general check-ins and psychiatrist visits) Receives: Drug: CI-581b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily occurrence of Heavy Drinking Days (HDD)
Defined as >4 drinks/day for men; >3 drinks for women. Comparing this outcome between groups that receive CI-581a versus CI-581b, as well as between CI-581a groups.
Measured: 12 weeks
Secondary outcomes (1)
Daily occurrence of drinking days
Comparing this outcome in between group that received CI-581a versus CI-581b, as well as between CI-581a groups.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start8 Nov 2019
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Elias Dakwar, New York State Psychiatric Institute
- Investigators
- Elias Dakwar, MD, Principal investigator, NYSPI/Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084860
- Sponsor's protocol ID
- 7889
- Other IDs
- 5R01AA027509-02
- Status last verified
- Nov 2023
- First submitted
- 4 Sep 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04084860
- Acronym / sponsor ID
- 7889
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed project tests the efficacy of glutamate modulators in non-depressed individuals with alcohol use disorder (AUD); the primary hypothesis is that the glutamate modulator being tested reduces heavy drinking days compared to the active control. It also aims to investigate, using a 2 by 2 factorial (2x2) design, the hypothesis that the effects of the glutamate modulator are enhanced when combined with behavioral treatment.
Detailed description
Alterations in glutamate neurotransmission are an important target of pharmacotherapy for alcohol use disorder. Our investigations with glutamate modulators in drug and alcohol dependent individuals suggest that they may exert unique therapeutic effects on dependence-related vulnerabilities and may also address problem drinking in alcohol dependent individuals. The proposed project will expand on our prior research by testing the efficacy of glutamate modulators in a larger population of non-depressed individuals with alcohol use disorder (AUD); it also aims to investigate, using a 2 by 2 factorial (2x2) design, the hypothesis that the effects of the glutamate modulator are enhanced when combined with behavioral treatment. It, therefore, has the potential to deepen our understanding of the therapeutic role of glutamate modulators in AUD treatment, as well as to provide further evidence for the efficacy of this novel pharmacotherapy strategy in addressing problem use
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CI-581a + MET/MBRP | Experimental | Drug: CI-581a, Behavioral: MBRP, Behavioral: METAdministration of CI-581a during weeks 1 and 6 at 0.71 mg/kg in the context of a 12 wk outpatient treatment (behavioral treatment combination of MET/MBRP will be provided) |
| CI-581a + Medication Management | Experimental | Drug: CI-581aAdministration of CI-581a during weeks 1 and 6 at 0.71 mg/kg in the context of a 12 wk outpatient treatment ( no MET/MBRP sessions will be provided, only general check-ins and psychiatrist visits) |
| CI-581b + MET/MBRP | Active comparator | Drug: CI-581b, Behavioral: MBRP, Behavioral: METAdministration of CI-581b during weeks 1 and 6 at 0.0125 mg/kg in the context of a 12 wk outpatient treatment (behavioral treatment combination of MET/MBRP will be provided) |
| CI-581b + Medication Management | Active comparator | Drug: CI-581bAdministration of CI-581b during weeks 1 and 6 at 0.0125 mg/kg in the context of a 12 wk outpatient treatment (no MET/MBRP sessions will be provided, only general check-ins and psychiatrist visits) |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Active alcohol use disorder, with at least 4 heavy drinking day over the past 7 days (greater than 4 drinks a day for males, greater than 3 drinks for females). In the case of the use of other drugs, alcohol is designated as the primary drug
- Physically healthy
- No adverse reactions to study medications
- 21-70 years of age
- Capacity to consent and comply with study procedures, including sufficient proficiency in English
Key exclusion criteria (11 listed)
- Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, or any psychotic illness, including substance-induced psychosis
- Physiological dependence on another substance, such as opioids or benzodiazepines, excluding caffeine, nicotine, and cannabis
- Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
- Current suicide risk or a history of suicide attempt within the past year
- Inability to safely initiate 24 hours of abstinence from alcohol, as evidenced by CIWA greater than 10 during screening; history of severe withdrawal phenomena over the past 6 months (e.g., inpatient stabilization, withdrawal-related seizure); or self-reported inability to maintain abstinence for 24 hours.
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 during weeks 1 and 6 at 0.71 mg/kg | Drug | CI-581a + MET/MBRP, CI-581a + Medication Management |
| CI-581bCI-581b during weeks 1 and 6 at 0.0125 mg/kg | Drug | CI-581b + MET/MBRP, CI-581b + Medication Management |
| MBRPAlso: Mindfulness Based Relapse Prevention (MBRP)MBRP will help with maintaining use reduction/abstinence.In this trial, 3 sessions will occur in the first 2 weeks following the second infusion (weeks 6 and 7), while one session a week will be administered in the latter 5 weeks (weeks 8 through 12). | Behavioural | CI-581a + MET/MBRP, CI-581b + MET/MBRP |
| METAlso: Motivational Enhancement Therapy (MET)MET may help with goal setting and enhancing engagement with MBRP. In this trial, a standard 5-week MET platform will be provided to individuals randomized to receive behavioral treatment, with an additional session after each infusion (7 sessions total). | Behavioural | CI-581a + MET/MBRP, CI-581b + MET/MBRP |
Primary outcome
Daily occurrence of Heavy Drinking Days (HDD)
Time frame: 12 weeks
Defined as >4 drinks/day for men; >3 drinks for women. Comparing this outcome between groups that receive CI-581a versus CI-581b, as well as between CI-581a groups.
1 secondary outcome
Daily occurrence of drinking days
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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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.
Elias Dakwar, MD contact
Elias Dakwar, MD principal investigator
NYSPI/Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CI-581a, CI-581b and MBRP in people with Alcohol Use Disorder, 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 11 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: looking for participants now, as of the sponsor's last update on 7 Nov 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate O'Malley (6467746103 ext. 6103, kate.omalley@nyspi.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily occurrence of Heavy Drinking Days (HDD) (time frame: 12 weeks). 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 7 Nov 2023.