Opioid-Related DisordersPhase 4DCNCT02978417
Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings
A Phase 4 study testing Naltrexone for extended-release injectable suspension and Oral naltrexone in people with Opioid-Related Disorders, run by Duke University at 1 site in United States.
Trial summary
In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness in drug courts, investigators propose a feasibility study in the Wake County, North Carolina drug court, where an estimated 50% of clients are opioid dependent. Aim 1: Pilot RCT. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Naltrexone for extended-release injectable suspension and Oral 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
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 30 Jun 2019
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Client of Wake County Drug Treatment Court
- Interested in medication-assisted treatment for opioid dependence
- 18-65 years old
- understands and speaks English
- understands that study participation is fully voluntary, with no effect on court standing
- willing and able to give written informed consent
Show all 11Show fewer
- has an opioid use disorder (DSM-5 diagnosis of moderate or severe opioid use disorder)
- has at least 6 months remaining before anticipated Drug Court graduation
- (if female) does not intend to become pregnant or breastfeeding during the study period and is willing to adhere to contraception requirements during the study period
- is willing to adhere to the study requirements
- Has at least 7-10 days without opioid use before beginning extended-release injectable naltrexone given that detoxification from opioids before initiating or resuming extended-release injectable naltrexone is necessary to prevent withdrawal.
Who cannot join
- Is pregnant (i.e., has a positive pregnancy test), planning to become pregnant, or breastfeeding during the study
- Has a positive urine drug test for opioids, buprenorphine or methadone at the beginning of treatment and before each Vivitrol® injection
- Has used any opioid drug within 10 days prior to treatment
- Has a condition, disease state, previous medical history, or observed abnormalities (including physical examination, laboratory evaluation [e.g., kidney or liver function test result], or urinalysis finding) at screening that, in the opinion of the investigator, would preclude safe participation in the study or affect the ability of the subject to adhere to the protocol visit schedule, fulfill visit requirements, or would interfere with the study assessments, including, but not limited to, the following:
- Uncontrolled hypertension, uncontrolled diabetes, renal disease/impairment, stroke, seizures or neurological disorder, cardiovascular (eg, endocarditis), neoplastic disease
- Chronic pain condition requiring ongoing opioid analgesia
Show all 13Show fewer
- Aspartate aminotransferase or alanine aminotransferase value ≥3 times the upper limit of normal
- Any contraindicated medical condition per the approved labeling for naltrexone
- Has had a DSM-5 diagnosis within the past 12 months of other psychiatric conditions or disorders that, in the investigator's opinion, could interfere with participation in the study
- Is currently physiologically dependent on any psychoactive substance (except caffeine, or tobacco) requiring medical intervention for detoxification
- Has a history of hypersensitivity or adverse reaction to naltrexone, or naloxone
- Has had significant suicidal ideation or behavior within the past year, as assessed with the Patient Health Questionnaire (PHQ-9)
- Note about exclusion criteria: If, after joining the study, a subject has a positive drug test, becomes pregnant, or acquires another exclusion condition that would have prevented him/her from joining the study, he or she may remain in the study but will not be permitted to receive Vivitrol®. Study staff will continue to gather interview data and administrative data on any enrolled, willing subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fellowship Health Resources (FHR)
Raleigh, North Carolina, 27612
About this study
Official title: A Feasibility Study for Testing the Effects of Extended-release Naltrexone (Vivitrol) on Recidivism and Other Participant Outcomes in Drug Court Settings
In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness in drug courts, investigators propose a feasibility study in the Wake County, North Carolina drug court, where an estimated 50% of clients are opioid dependent.
Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and eligible clients of the Wake County Drug Court.
Read the detailed description
Aim 1. Pilot RCT. The pilot delivery of Vivitrol® in the Wake County Drug Court will be carried out with 20-40 eligible drug court clients under treatment by Fellowship Health Resources, Inc. (FHR), the community behavioral health treatment agency that is the contracted treatment provider for the Wake County Drug Court. Participants will be randomized in equal number to receive Vivitrol® plus treatment as usual (TAU) or TAU only. TAU for drug court clients receiving services at FHR includes psychosocial treatment such as individual or group therapy, and sometimes also oral naltrexone for clients who are medically eligible and interested in taking the medication, the cost of which is covered by the agency for uninsured clients. (FHR currently administers Vivitrol® for a small number of interested agency clients with health insurance that covers the medication; the vast majority of their drug court clients are uninsured and so have no real access to the extended-release formulation due to its high cost.) Vivitrol® is an FDA-approved extended-release injectable form of naltrexone. Naltrexone is also available in oral, but not extended release, form. Naltrexone is an opioid antagonist that "blocks" opioid receptors in the brain to stop pleasurable feelings associated with taking opioids. Potentially eligible subjects will be drug court-referred FHR clients willing and eligible to take Vivitrol®, and willing to be randomly assigned to Vivitrol® or TAU. Potential subjects already under treatment with oral naltrexone at FHR would be eligible to enter the study if willing to switch to injectable Vivitrol® if randomly assigned. Study subjects who are randomized to Vivitrol® would receive a once-monthly injection of Vivitrol® for 12 months, or less if they decide to stop receiving Vivitrol® or to drop out of the study. Those randomized to TAU would continue with treatment as before, which could including (1) staying on oral naltrexone if already on it, (2) considering starting oral naltrexone, if interested, or (3) continuing with psychosocial treatment only. The Vivitrol® will be administered by study medical personnel at FHR. Randomization to the Vivitrol® arm would add urine pregnancy testing to FHR's existing Vivitrol® medical evaluation protocol and consent process, which currently screens for pregnancy without requiring a urine test. A urine pregnancy test will be administered once per month for female study participants of child-bearing age who are in the Vivitrol® group. All drug court clients, including study participants in both study groups, have urine drug tests at least once per week as part of program participation.
In addition to participating in Vivitrol® and psychosocial treatment, pilot RCT participants will provide consent for FHR and the drug court to share information with the study team about their demographic and clinical characteristics, treatment participation (e.g., outpatient group therapy), and court-related events (e.g., type of conviction that led to their drug court participation, missed drug court appointments, sanctions for program violations, and the results of drug screens).
Participants will also provide two face-to-face interviews at baseline and 6 months after baseline, about their interest and experience in Vivitrol® and/or other medication-assisted treatment (MAT), other treatment preferences, level of functioning, quality of life, and engagement in employment or education.
Outcome measures include treatment participation, compliance with drug court conditions, arrests and incarcerations, treatment satisfaction, and self-reported subjective measures of functioning and quality of life.
If a participant chooses not to participate in the study at any time, it will not affect his/her relationship with the court, FHR, right to health care, or participation in the study interview data collection. Site staff will follow participants for the purposes of collecting research and safety information. Investigators discontinue Vivitrol® or oral naltrexone in circumstances such as: adverse reactions to the medication; a change in medical status that makes it unsafe for a participant to continue receiving the medication, including pregnancy; or a participant becoming ill during the study. Participants who discontinue Vivitrol® or oral naltrexone for any reason may continue to participate in interviews for the study.
- Conditions
- Opioid-Related Disorders
- Being tested
- Naltrexone for extended-release injectable suspension, Oral naltrexone
- Keywords
- Medication-assisted treatment, Drug Court, Pilot study, Opioid dependence, Criminal justice
- 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.
Naltrexone for extended-release injectable suspensionDrug
Also called Vivitrol
Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 months if they continue to be medically eligible and willing.
Oral naltrexoneDrug
Also called Revia
Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
| Study group | Role | What they receive |
|---|---|---|
| Vivitrol | Active comparator | All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is naltrexone for extended-release injectable suspension. It is an injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Receives: Drug: Naltrexone for extended-release injectable suspension |
| Oral naltrexone | Active comparator | Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Receives: Drug: Oral naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With New Arrests
Any new arrests during the 12-month study period. This information will be collected from administrative records.
Measured: 12 months
Number of Participants With New Incarcerations
Any new incarceration during the 12-month study period. This information will be collected from administrative records.
Measured: 12 months
Secondary outcomes (13)
Number of Positive Drug Screens
Number of times a client had a positive drug screen. This information will be collected from administrative records.
Measured: 12 months
Number of Sanctions Imposed by the Court
Number of sanctions imposed by the court (e.g., brief stays in jail). This information will be collected from administrative records.
Measured: 12 months
Number of Missed Court Appointments
Number of missed court appointments during the 12-month study period. This information will be collected from administrative records.
Measured: 12 months
Vivitrol Participation
Number of Vivitrol injections from either arm of study. This information will be collected from administrative records.
Measured: 12 months
Treatment Participation (Non-Vivitrol)
Number of oral naltrexone monthly prescriptions from either arm of study. This information will be collected from administrative records.
Measured: 12 months
Change in Subjective Functioning: Medical Status
Subjective assessment of medical status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.
Measured: Baseline, 6 months
Number of Participants Who Reported Improvement in Subjective Functioning: Employment/Support Status
Subjective assessment of employment opportunities collected via interviews at baseline and approximately six months.
Measured: Baseline, 6 months
Number of Participants Who Reported Improvement in Substance Use
Subjective assessment of alcohol/drug use in past 30 days collected via interviews at baseline and approximately six months.
Measured: Baseline, 6 months
Number of Participants Who Reported Illegal Behavior
Subjective assessment of illegal behavior using the question, "Have you done anything that was against the law in the last 30 days?" collected via interviews approximately six months after baseline.
Measured: approximately 6 months
Number of Participants Who Reported Improvement in Subjective Functioning: Family/Social Relationships
Subjective assessment of family and social relationships using a single question about satisfaction with relationships over the past 30 days collected via interviews at baseline and approximately six months.
Measured: Baseline, approximately 6 months
Change in Subjective Functioning: Psychiatric Status
Subjective assessment of psychiatric status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.
Measured: Baseline, approximately 6 months
Treatment Satisfaction Score
Reported as average of 12-item treatment satisfaction score at approximately six months. A score of 5 indicates strong agreement with positive statements about treatment satisfaction; a score of 0 indicates strong disagreement.
Measured: Approximately 6 months
Change in Medication-assisted Treatment (MAT) Attitudes
Change in MAT attitudes from baseline to follow-up. The average score of 4 questions about MAT for substance use disorder were calculated at baseline and follow-up, and the average score at baseline was subtracted from the average score at follow-up. The averages are based on questions for which a score of 5 indicates strong agreement with statements about MAT; a score of 1 indicates strong disagreement with such statements.
Measured: Baseline, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start21 Sep 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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 Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Laura and John Arnold Foundation, Alkermes, Inc., FHR (Fellowship Health Resources, Inc.), Wake County Recovery Court
- Responsible party
- Sponsor
- Investigators
- Allison G Robertson, PhD, MPH, Principal investigator, Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978417
- Sponsor's protocol ID
- Pro00074507
- Other IDs
- 69665
- Acronym
- DC
- Status last verified
- Jun 2020
- First submitted
- 28 Nov 2016
- Last updated
- 16 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for Testing the Effects of Extended-release Naltrexone (Vivitrol) on Recidivism and Other Participant Outcomes in Drug Court Settings
- ClinicalTrials.gov ID
- NCT02978417
- Acronym / sponsor ID
- DC / Pro00074507
- Conditions
- Opioid-Related Disorders
- Keywords
- Medication-assisted treatment, Drug Court, Pilot study, Opioid dependence, Criminal justice
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Laura and John Arnold Foundation, Alkermes, Inc., FHR (Fellowship Health Resources, Inc.), Wake County Recovery Court
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Posted 16 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness in drug courts, investigators propose a feasibility study in the Wake County, North Carolina drug court, where an estimated 50% of clients are opioid dependent.
Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and eligible clients of the Wake County Drug Court.
Detailed description
Aim 1. Pilot RCT. The pilot delivery of Vivitrol® in the Wake County Drug Court will be carried out with 20-40 eligible drug court clients under treatment by Fellowship Health Resources, Inc. (FHR), the community behavioral health treatment agency that is the contracted treatment provider for the Wake County Drug Court. Participants will be randomized in equal number to receive Vivitrol® plus treatment as usual (TAU) or TAU only. TAU for drug court clients receiving services at FHR includes psychosocial treatment such as individual or group therapy, and sometimes also oral naltrexone for clients who are medically eligible and interested in taking the medication, the cost of which is covered by the agency for uninsured clients. (FHR currently administers Vivitrol® for a small number of interested agency clients with health insurance that covers the medication; the vast majority of their drug court clients are uninsured and so have no real access to the extended-release formulation due to its high cost.) Vivitrol® is an FDA-approved extended-release injectable form of naltrexone. Naltrexone is also available in oral, but not extended release, form. Naltrexone is an opioid antagonist that "blocks" opioid receptors in the brain to stop pleasurable feelings associated with taking opioids. Potentially eligible subjects will be drug court-referred FHR clients willing and eligible to take Vivitrol®, and willing to be randomly assigned to Vivitrol® or TAU. Potential subjects already under treatment with oral naltrexone at FHR would be eligible to enter the study if willing to switch to injectable Vivitrol® if randomly assigned. Study subjects who are randomized to Vivitrol® would receive a once-monthly injection of Vivitrol® for 12 months, or less if they decide to stop receiving Vivitrol® or to drop out of the study. Those randomized to TAU would continue with treatment as before, which could including (1) staying on oral naltrexone if already on it, (2) considering starting oral naltrexone, if interested, or (3) continuing with psychosocial treatment only. The Vivitrol® will be administered by study medical personnel at FHR. Randomization to the Vivitrol® arm would add urine pregnancy testing to FHR's existing Vivitrol® medical evaluation protocol and consent process, which currently screens for pregnancy without requiring a urine test. A urine pregnancy test will be administered once per month for female study participants of child-bearing age who are in the Vivitrol® group. All drug court clients, including study participants in both study groups, have urine drug tests at least once per week as part of program participation.
In addition to participating in Vivitrol® and psychosocial treatment, pilot RCT participants will provide consent for FHR and the drug court to share information with the study team about their demographic and clinical characteristics, treatment participation (e.g., outpatient group therapy), and court-related events (e.g., type of conviction that led to their drug court participation, missed drug court appointments, sanctions for program violations, and the results of drug screens).
Participants will also provide two face-to-face interviews at baseline and 6 months after baseline, about their interest and experience in Vivitrol® and/or other medication-assisted treatment (MAT), other treatment preferences, level of functioning, quality of life, and engagement in employment or education.
Outcome measures include treatment participation, compliance with drug court conditions, arrests and incarcerations, treatment satisfaction, and self-reported subjective measures of functioning and quality of life.
If a participant chooses not to participate in the study at any time, it will not affect his/her relationship with the court, FHR, right to health care, or participation in the study interview data collection. Site staff will follow participants for the purposes of collecting research and safety information. Investigators discontinue Vivitrol® or oral naltrexone in circumstances such as: adverse reactions to the medication; a change in medical status that makes it unsafe for a participant to continue receiving the medication, including pregnancy; or a participant becoming ill during the study. Participants who discontinue Vivitrol® or oral naltrexone for any reason may continue to participate in interviews for the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vivitrol | Active comparator | Drug: Naltrexone for extended-release injectable suspensionAll drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is naltrexone for extended-release injectable suspension. It is an injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). |
| Oral naltrexone | Active comparator | Drug: Oral naltrexoneSubjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Client of Wake County Drug Treatment Court
- Interested in medication-assisted treatment for opioid dependence
- 18-65 years old
- understands and speaks English
- understands that study participation is fully voluntary, with no effect on court standing
Key exclusion criteria (13 listed)
- Is pregnant (i.e., has a positive pregnancy test), planning to become pregnant, or breastfeeding during the study
- Has a positive urine drug test for opioids, buprenorphine or methadone at the beginning of treatment and before each Vivitrol® injection
- Has used any opioid drug within 10 days prior to treatment
- Has a condition, disease state, previous medical history, or observed abnormalities (including physical examination, laboratory evaluation [e.g., kidney or liver function test result], or urinalysis finding) at screening that, in the opinion of the investigator, would preclude safe participation in the study or affect the ability of the subject to adhere to the protocol visit schedule, fulfill visit requirements, or would interfere with the study assessments, including, but not limited to, the following:
- Has had a DSM-5 diagnosis within the past 12 months of other psychiatric conditions or disorders that, in the investigator's opinion, could interfere with participation in the study
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 |
|---|---|---|
| Naltrexone for extended-release injectable suspensionAlso: VivitrolOpioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 months if they continue to be medically eligible and willing. | Drug | Vivitrol |
| Oral naltrexoneAlso: ReviaOpioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing. | Drug | Oral naltrexone |
Primary outcome
Number of Participants With New Arrests
Time frame: 12 months
Any new arrests during the 12-month study period. This information will be collected from administrative records.
Number of Participants With New Incarcerations
Time frame: 12 months
Any new incarceration during the 12-month study period. This information will be collected from administrative records.
13 secondary outcomes
Number of Positive Drug Screens
Time frame: 12 months
Number of Sanctions Imposed by the Court
Time frame: 12 months
Number of Missed Court Appointments
Time frame: 12 months
Vivitrol Participation
Time frame: 12 months
Treatment Participation (Non-Vivitrol)
Time frame: 12 months
Change in Subjective Functioning: Medical Status
Time frame: Baseline, 6 months
Number of Participants Who Reported Improvement in Subjective Functioning: Employment/Support Status
Time frame: Baseline, 6 months
Number of Participants Who Reported Improvement in Substance Use
Time frame: Baseline, 6 months
Number of Participants Who Reported Illegal Behavior
Time frame: approximately 6 months
Number of Participants Who Reported Improvement in Subjective Functioning: Family/Social Relationships
Time frame: Baseline, approximately 6 months
Change in Subjective Functioning: Psychiatric Status
Time frame: Baseline, approximately 6 months
Treatment Satisfaction Score
Time frame: Approximately 6 months
Change in Medication-assisted Treatment (MAT) Attitudes
Time frame: Baseline, approximately 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Vivitrol prescribing informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Allison G Robertson, PhD, MPH principal investigator
Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone for extended-release injectable suspension and Oral naltrexone in people with Opioid-Related Disorders, run by Duke University 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 11 inclusion and 13 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 16 Jun 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 16 Jun 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?
Number of Participants With New Arrests (time frame: 12 months). The study lists 2 primary outcomes in all. 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 16 Jun 2020.