Opiate DependencePhase 2/3NCT01882361
Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
A Phase 2/3 study testing injectable naltrexone in people with Opiate Dependence and Human Immunodeficiency Virus, run by University of Pennsylvania at 1 site in Russia.
Trial summary
To address the question of the comparison of two courses of Vivitrol with differing lengths in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Dependence, Human Immunodeficiency Virus
- What is being tested?
- injectable naltrexone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2013to 31 Jul 2020
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-negative men and women 18 years of age or older who meet the Diagnostic and Statistical Manual of Mental Disorders 4th edition-Text Revision (DSM- IV-TR) criteria for opioid dependence
- Must be voluntarily seeking treatment for opioid dependence, with injection heroin as the drug and administration route of choice
- Must report sharing injection equipment during the past year
- Must have successfully completed inpatient detoxification at the Federal Medical Research Center for Psychiatry and Narcology (FMRCPN)
- Must have no current evidence of physiologic dependence
- Must have a stable address in Moscow with a telephone number where they can be reached
- If female, must have a negative pregnancy test and use of medically acceptable contraception if of childbearing age
- Must be able to provide informed consent as judged by the ability to read the consent and correctly answer 9 out of 10 questions about the study on a quiz
Who cannot join
- No current condition of psychosis (schizophrenia,paranoid disorder, mania)
- No history of major psychiatric disorders such as Schizophrenia, Major Depression with suicidal attempts, Bipolar I, uncontrolled epilepsy or other seizure disorder
- No current dependence (within the past year) to drugs other than prescription opiates or heroin, caffeine, marijuana, or nicotine based on the Diagnostic and Statistical Manual of Mental Disorders-Text Revision (DSM -IV-TR) criteria
- No current alcohol dependence or alcohol use disorder that would preclude successful completion of study procedures
- No current suicidal or homicidal ideation requiring immediate attention as determined at baseline assessment
- No cognitive impairment with inability to read and understand the consent
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- No significant laboratory abnormality such as haemoglobin <10, hepatic transaminase levels >3 times upper limit of normal or serum creatinine that is >1.5 times upper limit of normal
- No legal charges with impending incarceration
- No concurrent participation in another treatment study
- Cannot be scheduled for surgery or be likely to require opioids for pain control in next 2 years
- Not currently taking naltrexone or currently receiving other treatment (pharmacological or behavioral) for drug dependence or currently receiving psychoactive medication
- Cannot have had receipt of any approved or investigational depot product administered into the gluteal muscle within 6 months before screening
- Cannot be on any excluded medication at screening or be anticipating the use of an excluded medication during the study period
- Cannot have participated in a clinical trial of a pharmacological agent within 30 days prior to screening
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Medical Research Center for Psychiatry and Narcology (FMRC)
Moscow, 119002
About this study
To address the question of the comparison of two courses of Vivitrol with differing lengths in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient treatment. Participants will be randomized under double blind conditions to a 24 or 48-week course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections in weeks 24 to 48.
Read the detailed description
1.2.1 Primary and Secondary Outcome Measures
Primary outcomes are:
- Opiate positive urine tests; 2) HIV injecting risk.
Secondary outcomes are:
- Time to relapse; 2) HIV sex risk; 3) Proportion of appointments kept; 6) Psychiatric symptoms; 7) Opioid craving; 8) Self-reported drug use; 9) Money spent for drugs; 10) Employment; 11) Arrests; 12) Overall adjustment; 12) Adverse events.
Hypotheses are that:
- Primary outcomes will significantly favor the 48-week Vivitrol condition;
- Five or more secondary outcomes will favor the 48-week condition; none will favor the 24-week condition.
- Conditions
- Opiate Dependence, Human Immunodeficiency Virus
- Being tested
- injectable naltrexone, placebo comparator
- Keywords
- opioid addiction, opioid treatment, naloxone
- Medical subject headings
- Opioid-Related Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable naltrexoneDrug
Also called Vivitrol
Vivitrol is an extended-release, microsphere formulation of naltrexone designed to be administered by intramuscular (IM) gluteal injection every 4 weeks or once a month. After IM injection, the naltrexone plasma concentration time profile is characterized by a transient initial peak, which occurs approximately 2 hours after injection, followed by a second peak observed approximately 2 - 3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month.
placebo comparatorDrug
this placebo has no specific pharmacological activity
| Study group | Role | What they receive |
|---|---|---|
| injectable naltrexone | Active comparator | One dose of injectable extended release naltrexone (Vivitrol), 380mg dosage, given every four weeks in a 48-week trial. Receives: Drug: injectable naltrexone |
| placebo injection for naltrexone | Placebo comparator | placebo comparator injection starting at week 24 in a 48-week trial. Receives: Drug: placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate positive urine tests
Reduction in drug use as seen by the primary urine outcomes will significantly favor the 48-week Vivitrol condition
Measured: 12 months
Secondary outcomes (1)
HIV sex risk
Participants will show significant HIV sex risk behaviors in the 48-week vivitrol condition.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJun 2013
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- George E Woody, MD, Principal investigator, University of PennsylvaniaTatiana Klimenko, MD, PhD, Principal investigator, Federal Medical Research Center for Psychiatry and Narcology (FMRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882361
- Sponsor's protocol ID
- 816019
- Other IDs
- R01DA033670
- Status last verified
- Nov 2020
- First submitted
- 14 Jun 2013
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
- ClinicalTrials.gov ID
- NCT01882361
- Acronym / sponsor ID
- 816019
- Conditions
- Opiate Dependence, Human Immunodeficiency Virus
- Keywords
- opioid addiction, opioid treatment, naloxone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2013 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 20 Jun 2013 (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.
To address the question of the comparison of two courses of Vivitrol with differing lengths in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient treatment. Participants will be randomized under double blind conditions to a 24 or 48-week course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections in weeks 24 to 48.
Detailed description
1.2.1 Primary and Secondary Outcome Measures
Primary outcomes are:
- Opiate positive urine tests; 2) HIV injecting risk.
Secondary outcomes are:
- Time to relapse; 2) HIV sex risk; 3) Proportion of appointments kept; 6) Psychiatric symptoms; 7) Opioid craving; 8) Self-reported drug use; 9) Money spent for drugs; 10) Employment; 11) Arrests; 12) Overall adjustment; 12) Adverse events.
Hypotheses are that:
- Primary outcomes will significantly favor the 48-week Vivitrol condition;
- Five or more secondary outcomes will favor the 48-week condition; none will favor the 24-week condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injectable naltrexone | Active comparator | Drug: injectable naltrexoneOne dose of injectable extended release naltrexone (Vivitrol), 380mg dosage, given every four weeks in a 48-week trial. |
| placebo injection for naltrexone | Placebo comparator | Drug: placebo comparatorplacebo comparator injection starting at week 24 in a 48-week trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV-negative men and women 18 years of age or older who meet the Diagnostic and Statistical Manual of Mental Disorders 4th edition-Text Revision (DSM- IV-TR) criteria for opioid dependence
- Must be voluntarily seeking treatment for opioid dependence, with injection heroin as the drug and administration route of choice
- Must report sharing injection equipment during the past year
- Must have successfully completed inpatient detoxification at the Federal Medical Research Center for Psychiatry and Narcology (FMRCPN)
- Must have no current evidence of physiologic dependence
Key exclusion criteria (14 listed)
- No current condition of psychosis (schizophrenia,paranoid disorder, mania)
- No history of major psychiatric disorders such as Schizophrenia, Major Depression with suicidal attempts, Bipolar I, uncontrolled epilepsy or other seizure disorder
- No current dependence (within the past year) to drugs other than prescription opiates or heroin, caffeine, marijuana, or nicotine based on the Diagnostic and Statistical Manual of Mental Disorders-Text Revision (DSM -IV-TR) criteria
- No current alcohol dependence or alcohol use disorder that would preclude successful completion of study procedures
- No current suicidal or homicidal ideation requiring immediate attention as determined at baseline assessment
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 |
|---|---|---|
| injectable naltrexoneAlso: VivitrolVivitrol is an extended-release, microsphere formulation of naltrexone designed to be administered by intramuscular (IM) gluteal injection every 4 weeks or once a month. After IM injection, the naltrexone plasma concentration time profile is characterized by a transient initial peak, which occurs approximately 2 hours after injection, followed by a second peak observed approximately 2 - 3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month. | Drug | injectable naltrexone |
| placebo comparatorthis placebo has no specific pharmacological activity | Drug | placebo injection for naltrexone |
Primary outcome
Opiate positive urine tests
Time frame: 12 months
Reduction in drug use as seen by the primary urine outcomes will significantly favor the 48-week Vivitrol condition
1 secondary outcome
HIV sex risk
Time frame: 12 months
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 6 Nov 2020.
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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.
George E Woody, MD principal investigator
University of Pennsylvania
Tatiana Klimenko, MD, PhD principal investigator
Federal Medical Research Center for Psychiatry and Narcology (FMRC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing injectable naltrexone in people with Opiate Dependence and Human Immunodeficiency Virus, run by University of Pennsylvania at 1 site in Russia.
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 8 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: finished, as of the sponsor's last update on 6 Nov 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 Russia. 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 combined 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.
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?
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?
Opiate positive urine tests (time frame: 12 months). 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 6 Nov 2020.