Opioid DependencePhase 3NCT03345173
Facilitating Rapid Naltrexone Initiation
A Phase 3 study testing CI-581-a and CI-581-b in people with Opioid Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The incidence of opioid use disorders (OUDs) has increased to near-epidemic proportions. While maintenance with long-acting opioids such as methadone or buprenorphine represents an effective treatment strategy, it may be unacceptable to many individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- CI-581-a and CI-581-b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2017to Oct 2024
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-5 criteria of current opioid use disorder present for at least six months, supported by a positive urine for opioids or a positive naloxone challenge test
- Aged 18 to 70 years
- In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges
- Able to give written informed consent to participate in the study
- Interested in maintenance treatment with extended-release naltrexone
Who cannot join
- Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal requiring medical management
- Methadone maintenance treatment or regular use of illicit methadone (>30 mg per week); urine toxicology positive for methadone at admission
- Buprenorphine maintenance treatment or regular use of buprenorphine (>16 mg per week); urine toxicology positive for buprenorphine at admission
- Active, or past, psychiatric disorder(s) which might interfere with participation or make participation hazardous, including DSM-V mental disorder due to another medical condition, major depressive disorder, psychotic disorder, or bipolar disorder with psychotic features
- Significant current suicidal risk or a suicide attempt within the past year
- On psychotropic or other medications that may interact adversely with study medications, or whose effect might be disrupted by study medications
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- For women of childbearing potential: positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
- 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), 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 the study medications in combination with this medication may increase the risk of drug-induced hepatitis
- Acute hepatitis with SGOT or SGPT > 3 times the upper end of the laboratory normal range
- Concurrent participation in another treatment study or another substance abuse program with the exception of a self-help group
- History of allergy or sensitivity to any study medication
- Ongoing chronic pain that may require opioid management, or for which surgery is indicated
- History of inability to tolerate study medications
- History of a use disorder with the study medications
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Glutamatergic Modulation to Facilitate Naltrexone Initiation: A Randomized, Controlled Trial
The incidence of opioid use disorders (OUDs) has increased to near-epidemic proportions. While maintenance with long-acting opioids such as methadone or buprenorphine represents an effective treatment strategy, it may be unacceptable to many individuals. As a result, long-acting injectable naltrexone (XR-NTX), an antagonist medication that blocks the effects of opioids for at least 4 weeks, is now indicated for relapse prevention following detoxification. This randomized, controlled trial aims to test the efficacy of a glutamate modulator at facilitating a rapid non-opioid based naltrexone induction.
Read the detailed description
This study combines a nonopioid detoxification; a naltrexone titration schedule that allows for pushing the dose rapidly while monitoring closely to ensure tolerability; and infusions integrated into the treatment in such a way as to potentially ameliorate spontaneous and precipitated withdrawal. The first part of the treatment trial involves receiving inpatient treatment for up to 5 days. Following week 1, participants will meet with staff twice weekly and receive 12 weeks of mindfulness based relapse prevention and motivational interviewing sessions.
- Conditions
- Opioid Dependence
- Being tested
- CI-581-a, CI-581-b
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CI-581-aDrug
Two infusions in the context of naltrexone induction protocol.
CI-581-bDrug
Two infusions in the context of naltrexone induction protocol.
| Study group | Role | What they receive |
|---|---|---|
| CI-581a | Experimental | CI-581a will be administered during the washout phase when participants are experiencing moderate withdrawal, as well as the following day when the naltrexone titration is initiated.
(0.11 mg/kg 2-min bolus followed by 1.3 mg/kg over 90 min) Receives: Drug: CI-581-a |
| CI-581b | Placebo comparator | CI-581b will be administered during the washout phase when participants are experiencing moderate withdrawal, as well as the following day when the naltrexone titration is initiated.
(2-min saline bolus followed by 0.0125 mg/kg over 90 min) Receives: Drug: CI-581-b |
What is being measured
The primary outcome is the main question the study is designed to answer.
XR-NTX Initiation
Initiation of XR-NTX during the inpatient induction, without dropout or buprenorphine initiation.
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start25 Nov 2017
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
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, NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345173
- Sponsor's protocol ID
- 7543
- Other IDs
- 5R01DA042070-04
- Status last verified
- Feb 2024
- First submitted
- 13 Nov 2017
- Last updated
- 2 Feb 2024
- 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutamatergic Modulation to Facilitate Naltrexone Initiation: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03345173
- Acronym / sponsor ID
- 7543
- Conditions
- Opioid Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Nov 2017 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 17 Nov 2017 (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 incidence of opioid use disorders (OUDs) has increased to near-epidemic proportions. While maintenance with long-acting opioids such as methadone or buprenorphine represents an effective treatment strategy, it may be unacceptable to many individuals. As a result, long-acting injectable naltrexone (XR-NTX), an antagonist medication that blocks the effects of opioids for at least 4 weeks, is now indicated for relapse prevention following detoxification. This randomized, controlled trial aims to test the efficacy of a glutamate modulator at facilitating a rapid non-opioid based naltrexone induction.
Detailed description
This study combines a nonopioid detoxification; a naltrexone titration schedule that allows for pushing the dose rapidly while monitoring closely to ensure tolerability; and infusions integrated into the treatment in such a way as to potentially ameliorate spontaneous and precipitated withdrawal. The first part of the treatment trial involves receiving inpatient treatment for up to 5 days. Following week 1, participants will meet with staff twice weekly and receive 12 weeks of mindfulness based relapse prevention and motivational interviewing sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CI-581a | Experimental | Drug: CI-581-aCI-581a will be administered during the washout phase when participants are experiencing moderate withdrawal, as well as the following day when the naltrexone titration is initiated. (0.11 mg/kg 2-min bolus followed by 1.3 mg/kg over 90 min) |
| CI-581b | Placebo comparator | Drug: CI-581-bCI-581b will be administered during the washout phase when participants are experiencing moderate withdrawal, as well as the following day when the naltrexone titration is initiated. (2-min saline bolus followed by 0.0125 mg/kg over 90 min) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DSM-5 criteria of current opioid use disorder present for at least six months, supported by a positive urine for opioids or a positive naloxone challenge test
- Aged 18 to 70 years
- In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges
- Able to give written informed consent to participate in the study
- Interested in maintenance treatment with extended-release naltrexone
Key exclusion criteria (14 listed)
- Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal requiring medical management
- Methadone maintenance treatment or regular use of illicit methadone (>30 mg per week); urine toxicology positive for methadone at admission
- Buprenorphine maintenance treatment or regular use of buprenorphine (>16 mg per week); urine toxicology positive for buprenorphine at admission
- Active, or past, psychiatric disorder(s) which might interfere with participation or make participation hazardous, including DSM-V mental disorder due to another medical condition, major depressive disorder, psychotic disorder, or bipolar disorder with psychotic features
- Significant current suicidal risk or a suicide attempt within the past year
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-581-aTwo infusions in the context of naltrexone induction protocol. | Drug | CI-581a |
| CI-581-bTwo infusions in the context of naltrexone induction protocol. | Drug | CI-581b |
Primary outcome
XR-NTX Initiation
Time frame: From baseline to week 12
Initiation of XR-NTX during the inpatient induction, without dropout or buprenorphine initiation.
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 2 Feb 2024.
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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
NYSPI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CI-581-a and CI-581-b in people with Opioid 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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2024. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
XR-NTX Initiation (time frame: From baseline to week 12). 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 2 Feb 2024.