Opioid Use DisorderPhase 1NCT02593474
Medication-Assisted Treatment for Youth With Substance Use Disorders
A Phase 1 study testing Naltrexone in people with Opioid Use Disorder and Opioid Dependence, run by New York State Psychiatric Institute at 2 sites in United States.
Trial summary
The purpose of this open-label pilot study is to determine the tolerability and applicability of outpatient long-acting injectable naltrexone (Vivitrol) treatment in individuals age 16-25 ("older youth") with opioid use disorder. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Opioid Use Disorder, Opioid Dependence
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females 16-25 years of age
- If adult participant (>18 y/o), capacity to provide informed consent
- If minor participants (<18 y/o), capacity to assent
- If minor participants (<18 y/o), a legal guardian available to give informed consent and accompany minor participant to all appointments or formally designate another responsible adult to accompany the minor participant to the appointments subsequent to the initial visit.
- DSM-5 criteria for opioid use disorder as a primary diagnosis
- Psychiatrically stable
Show all 10Show fewer
- Physically healthy
- Voluntarily seeking outpatient opioid antagonist treatment
- Able to perform study procedures
- English speaking
Who cannot join
- History of allergy intolerance or hypersensitivity to the study medications
- Meets DSM-5 criteria for substance use disorder other than opioid use disorder as the primary diagnosis (except nicotine or caffeine)
- Comorbid psychiatric disorder that might interfere with or make participation hazardous, including DSM-5 diagnosis of a psychotic disorder, severe major depressive disorder, or any psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or nonpharmacological intervention during the course of the study
- Pregnancy, lactation within the last 6 months, or failure to use effective contraceptive methods (condoms, diaphragm, birth control pill, IUD) in sexually active females
- Methadone maintenance treatment or regular use of illicit methadone (>30 mg per week)
- Maintenance on, or regular use of, buprenorphine or other long-acting opioid agonists
Show all 10Show fewer
- Current suicide risk or any suicide attempts within the past year
- Unstable medical conditions or laboratory test data, which might make participation hazardous, such as acute hepatitis or ALT or AST > 3 times normal
- History of accidental drug overdose in the last three years defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received
- Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York State Psychiatric Insitute
New York, New York, 10032
New York State Psychiatric Institute
New York, New York, 10032
About this study
The purpose of this open-label pilot study is to determine the tolerability and applicability of outpatient long-acting injectable naltrexone (Vivitrol) treatment in individuals age 16-25 ("older youth") with opioid use disorder. Outpatient treatment will consist of a 7-day outpatient detoxification / naltrexone induction procedure followed by 8-weeks of treatment with Vivitrol.
Read the detailed description
The rates of opioid use in youth are rising. Long-acting injectable naltrexone (Vivitrol), a medication that blocks the effects of opioid drugs, has been shown to be effective for treatment of opioid dependence in adults. Vivitrol is an important option for individuals not wanting agonist treatment (e.g. buprenorphine, methadone). Vivitrol may be particularly appealing to youth who have difficulty reaching their opioid use goals with daily oral medications as it is a monthly injection and therefore eliminates the problem of daily medication non-adherence. Vivitrol may also be appealing to families as it reduces conflicts around issues of adherence and thus supports positive parenting. Whereas Vivitrol has been used clinically in minors, it has not been studied in a prospective outpatient trial. Starting naltrexone, however, can be challenging in opioid-dependent individuals because detoxification is required prior to treatment with this medication.There are no standard outpatient detoxification protocols for opioid-dependent youth. Therefore, more studies are needed to support broader and approved use of Vivitrol in this population.
The purpose of this open-label pilot study is to determine the tolerability and applicability of outpatient long-acting injectable naltrexone (Vivitrol) treatment in individuals age 16-25 ("older youth") with opioid use disorder. We aim to have 16 older youth complete this trial. Participants will undergo an outpatient detoxification / induction procedure that has been honed over the past 13 years of work with this medication by others in our Division and is currently being used safely in opioid-dependent adults in an ongoing clinical trial. The detoxification / induction procedure consists of a single day of buprenorphine followed by a washout day and 4 days of ascending oral naltrexone doses prior to administering a dose of injectable naltrexone, typically at Day 8. Participants will then receive an additional Vivitrol injection 4 weeks after the first; they will also receive weekly medication management therapy with a research psychiatrist. Following the 9 week trial, participants and are eligible for an additional third injection followed by up to 4 weeks of therapy while proper follow-up treatment is arranged.
Primary Aim: To determine the tolerability and applicability of outpatient Vivitrol treatment in individuals aged 16-25 ("older youth") with opioid use disorder as determined by retention in treatment across the study. Outpatient treatment will consist of a 7-day detoxification / naltrexone induction procedure followed by 8-weeks of treatment with Vivitrol.
Secondary Aim 1:To determine the tolerability of 7-day outpatient detoxification / naltrexone induction for older youth as assessed by retention through first administration of Vivitrol.
Secondary Aim 2:To determine the tolerability of initial (4-week) treatment with Vivitrol as assessed by receipt of the second Vivitrol injection at week 4.
Secondary Aim 3:To determine the safety and tolerability of Vivitrol treatment as assessed with measures of adverse events.
- Conditions
- Opioid Use Disorder, Opioid Dependence
- Being tested
- Naltrexone
- Keywords
- Adolescent, Youth
- 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.
NaltrexoneDrug
Also called Long acting naltrexone, Vivitrol
Outpatient detoxification and induction onto long-acting naltrexone followed by an additional second injection of long-acting naltrexone and and additional third if desired.
| Study group | Role | What they receive |
|---|---|---|
| Detoxification / induction | Other | The detoxification / induction procedure consists of a single day of buprenorphine followed by a washout day and 4 days of ascending oral naltrexone doses. Followed on day 8 by Vivitrol injection. Participants then receive a second injection 4 weeks after the first. Receives: Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment at week 9 - the end of the study (this includes 1wk detox and 8 wks of treatment with Vivitrol)
Measured: 9 weeks
Secondary outcomes (1)
Retention through first administration of Vivitrol (ie number that receive first injection)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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, Elizabeth Evans, New York State Psychiatric Institute
- Investigators
- Elizabeth Evans, MD, Principal investigator, Columbia University / New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593474
- Sponsor's protocol ID
- #7146
- Other IDs
- U54DA037842
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2015
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication-Assisted Treatment for Youth With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT02593474
- Acronym / sponsor ID
- #7146
- Conditions
- Opioid Use Disorder, Opioid Dependence
- Keywords
- Adolescent, Youth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 2 Nov 2015 (estimated)
- 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 purpose of this open-label pilot study is to determine the tolerability and applicability of outpatient long-acting injectable naltrexone (Vivitrol) treatment in individuals age 16-25 ("older youth") with opioid use disorder. Outpatient treatment will consist of a 7-day outpatient detoxification / naltrexone induction procedure followed by 8-weeks of treatment with Vivitrol.
Detailed description
The rates of opioid use in youth are rising. Long-acting injectable naltrexone (Vivitrol), a medication that blocks the effects of opioid drugs, has been shown to be effective for treatment of opioid dependence in adults. Vivitrol is an important option for individuals not wanting agonist treatment (e.g. buprenorphine, methadone). Vivitrol may be particularly appealing to youth who have difficulty reaching their opioid use goals with daily oral medications as it is a monthly injection and therefore eliminates the problem of daily medication non-adherence. Vivitrol may also be appealing to families as it reduces conflicts around issues of adherence and thus supports positive parenting. Whereas Vivitrol has been used clinically in minors, it has not been studied in a prospective outpatient trial. Starting naltrexone, however, can be challenging in opioid-dependent individuals because detoxification is required prior to treatment with this medication.There are no standard outpatient detoxification protocols for opioid-dependent youth. Therefore, more studies are needed to support broader and approved use of Vivitrol in this population.
The purpose of this open-label pilot study is to determine the tolerability and applicability of outpatient long-acting injectable naltrexone (Vivitrol) treatment in individuals age 16-25 ("older youth") with opioid use disorder. We aim to have 16 older youth complete this trial. Participants will undergo an outpatient detoxification / induction procedure that has been honed over the past 13 years of work with this medication by others in our Division and is currently being used safely in opioid-dependent adults in an ongoing clinical trial. The detoxification / induction procedure consists of a single day of buprenorphine followed by a washout day and 4 days of ascending oral naltrexone doses prior to administering a dose of injectable naltrexone, typically at Day 8. Participants will then receive an additional Vivitrol injection 4 weeks after the first; they will also receive weekly medication management therapy with a research psychiatrist. Following the 9 week trial, participants and are eligible for an additional third injection followed by up to 4 weeks of therapy while proper follow-up treatment is arranged.
Primary Aim: To determine the tolerability and applicability of outpatient Vivitrol treatment in individuals aged 16-25 ("older youth") with opioid use disorder as determined by retention in treatment across the study. Outpatient treatment will consist of a 7-day detoxification / naltrexone induction procedure followed by 8-weeks of treatment with Vivitrol.
Secondary Aim 1:To determine the tolerability of 7-day outpatient detoxification / naltrexone induction for older youth as assessed by retention through first administration of Vivitrol.
Secondary Aim 2:To determine the tolerability of initial (4-week) treatment with Vivitrol as assessed by receipt of the second Vivitrol injection at week 4.
Secondary Aim 3:To determine the safety and tolerability of Vivitrol treatment as assessed with measures of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Detoxification / induction | Other | Drug: NaltrexoneThe detoxification / induction procedure consists of a single day of buprenorphine followed by a washout day and 4 days of ascending oral naltrexone doses. Followed on day 8 by Vivitrol injection. Participants then receive a second injection 4 weeks after the first. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Males or females 16-25 years of age
- If adult participant (>18 y/o), capacity to provide informed consent
- If minor participants (<18 y/o), capacity to assent
- If minor participants (<18 y/o), a legal guardian available to give informed consent and accompany minor participant to all appointments or formally designate another responsible adult to accompany the minor participant to the appointments subsequent to the initial visit.
- DSM-5 criteria for opioid use disorder as a primary diagnosis
Key exclusion criteria (10 listed)
- History of allergy intolerance or hypersensitivity to the study medications
- Meets DSM-5 criteria for substance use disorder other than opioid use disorder as the primary diagnosis (except nicotine or caffeine)
- Comorbid psychiatric disorder that might interfere with or make participation hazardous, including DSM-5 diagnosis of a psychotic disorder, severe major depressive disorder, or any psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or nonpharmacological intervention during the course of the study
- Pregnancy, lactation within the last 6 months, or failure to use effective contraceptive methods (condoms, diaphragm, birth control pill, IUD) in sexually active females
- Methadone maintenance treatment or regular use of illicit methadone (>30 mg per week)
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 |
|---|---|---|
| NaltrexoneAlso: Long acting naltrexone, VivitrolOutpatient detoxification and induction onto long-acting naltrexone followed by an additional second injection of long-acting naltrexone and and additional third if desired. | Drug | Detoxification / induction |
Primary outcome
Retention in treatment at week 9 - the end of the study (this includes 1wk detox and 8 wks of treatment with Vivitrol)
Time frame: 9 weeks
1 secondary outcome
Retention through first administration of Vivitrol (ie number that receive first injection)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
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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.
Elizabeth Evans, MD principal investigator
Columbia University / New York State Psychiatric Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naltrexone in people with Opioid Use Disorder and Opioid Dependence, run by New York State Psychiatric Institute at 2 sites 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 10 inclusion and 10 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 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retention in treatment at week 9 - the end of the study (this includes 1wk detox and 8 wks of treatment with Vivitrol) (time frame: 9 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 31 Oct 2018.