Opiate DependencePhase 2BUP/NXT-VIVINCT01690546
Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
A Phase 2 study testing very low dose naltrexone, extended release naltrexone and buprenorphine/naloxone in people with Opiate Dependence, run by Paolo Mannelli at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- very low dose naltrexone, extended release naltrexone and buprenorphine/naloxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Feb 2015
- Phase
- Phase 2
- 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
- Men and women 18 to 65 years of age who meet DSM-IV criteria for OD of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
- Individuals must be capable of giving informed consent and capable of complying with study procedures.
- Participants will be asked to provide locator information including the address and telephone number of a non-drug abusing relative or friend who can reach the participant in emergencies.
Who cannot join
- Individuals currently prescribed or regularly taking opiates for chronic pain or medical illness.
- Individuals regularly using licit or illicit methadone or BUP.
- Individuals meeting DSM-IV criteria for schizophrenia, schizoaffective or psychotic disorders, or psychiatric disorder (other than substance abuse) requiring intervention.
- Individuals who are medically unstable, or have liver enzyme function tests greater than two times normal.
- Individuals with current suicidal risk or 1 or more suicide attempts within the past year.
- History of accidental drug overdose in the last three years or any other significant history of overdose following detoxification, defined as an episode of opioid-induced unconsciousness or incapacitation.
Show all 11Show fewer
- Nursing/pregnant women, or failure in a sexually active man or woman to use adequate contraceptive methods (e.g., oral or depot contraceptives, foam, sponges, and/or condoms)
- Individuals who are dependent on any other drugs (excluding nicotine)
- Individuals with known sensitivity to BUP, VIVITROL, NTX, naloxone.
- Individuals who are court-mandated to treatment.
- Individuals who have a current or pending legal status, or any other condition that would make them unlikely to be available for the duration of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center / Civitan Building
Durham, North Carolina, 27705
About this study
Official title: An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction
The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.
Read the detailed description
Thirty-five opioid dependent (OD) volunteers seeking treatment will be enrolled in an open-label, flexible-dosing, outpatient trial at Duke Addictions Program. On days 1-3, participants will receive buprenorphine/naloxone daily at a starting dose of 4mg, progressively decreasing to 2 mg on days 2- 3. Participants will also receive very low dose naltrexone (VLNTX) at a dose of 0.25 mg to 1mg on Days 1-3, 2 to 6 mg on Day 4 and between 10 and 50 mg on Days 5-7. Then a VIVITROL injection, 380 mg, will be administered on Day 8.
Evaluations will occur daily for up to 6 hours until 1 day after VIVITROL injection and then weekly for 4 weeks. Patients will receive ancillary medications as needed and weekly psychosocial intervention. At the end of the study, participants will be offered outpatient treatment of OD at the study site, or will be referred to other treatment programs.
- Conditions
- Opiate Dependence
- Being tested
- very low dose naltrexone, extended release naltrexone, buprenorphine/naloxone
- Keywords
- Opioid Addiction, Addiction, Drug Dependence
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
very low dose naltrexoneDrug
On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
extended release naltrexoneDrug
Also called Vivitrol
On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
buprenorphine/naloxoneDrug
Also called Suboxone
On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
| Study group | Role | What they receive |
|---|---|---|
| BUP/VLNXT to VIVITROL | Experimental | On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. Receives: Drug: very low dose naltrexone; Drug: extended release naltrexone; Drug: buprenorphine/naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in Treatment
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks.
Measured: 4 weeks
Secondary outcomes (9)
Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.
COWS rates eleven common opiate withdrawal signs or symptoms. The summed scores ranged from 0-48, with 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.
Measured: 4 weeks
Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.
SOWS contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). Total score range is 0 - 64; the higher the score the more withdrawal symptoms.
Measured: 4 weeks
Craving
Craving, assessed with a 100-point Visual Analog Scale (VAS), ranging from 'not at all' (0) to 'more than ever' (100). The higher the score the higher the craving.
Measured: 4 weeks
Illicit Drug Use, Measured by Urine Drug Testing
number of participants that tested positive for marijuana, cocaine, and opiates.
Measured: 4 weeks
Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire
Questionnaire consisted of 3 questions.
- Were you satisfied with the treatment (range 1-5): Completely satisfied (1) to completely dissatisfied (5).
- Were you satisfied with withdrawal treatment (range 1-5): Minimal withdrawal (1) to worse than ever (5).
- Did the medication help (range 1-5): Helped a lot (1) to No it did not help (5).
Lower scores represent greater satisfaction.
Measured: Day 9
Percentage of Participants Who Adhered to Study Visits.
Measured: baseline to end of study (approximately 40 days)
Percentage of Participants With Adherence to Medication (Naltrexone)
Participant who took Naltrexone as prescribed.
Measured: Day 1 to Day 8 (+/- 2 days)
Use of Ancillary Medications.
Number of participants that took ancillary medication
Measured: baseline to week 1
Number of Participants That Self Reported Illicit Drug Use
Participants reported on any illicit drug use to include Cocaine marijuana opiates
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2015
- Study completionFeb 2015
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 Opiate 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paolo Mannelli
- Sponsor type
- University, hospital or other
- Collaborators
- Alkermes, Inc.
- Responsible party
- Sponsor-investigator, Paolo Mannelli, Duke University
- Investigators
- Paolo Mannelli, MD, Principal investigator, Duke University Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690546
- Sponsor's protocol ID
- Pro00036909
- Acronym
- BUP/NXT-VIVI
- Status last verified
- Apr 2016
- First submitted
- 19 Sep 2012
- Last updated
- 1 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction
- ClinicalTrials.gov ID
- NCT01690546
- Acronym / sponsor ID
- BUP/NXT-VIVI / Pro00036909
- Conditions
- Opiate Dependence
- Keywords
- Opioid Addiction, Addiction, Drug Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Paolo MannelliUniversity, hospital or other
- Collaborators
- Alkermes, Inc.
- Study start
- Sep 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Posted 1 Jun 2016
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 study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.
Detailed description
Thirty-five opioid dependent (OD) volunteers seeking treatment will be enrolled in an open-label, flexible-dosing, outpatient trial at Duke Addictions Program. On days 1-3, participants will receive buprenorphine/naloxone daily at a starting dose of 4mg, progressively decreasing to 2 mg on days 2- 3. Participants will also receive very low dose naltrexone (VLNTX) at a dose of 0.25 mg to 1mg on Days 1-3, 2 to 6 mg on Day 4 and between 10 and 50 mg on Days 5-7. Then a VIVITROL injection, 380 mg, will be administered on Day 8.
Evaluations will occur daily for up to 6 hours until 1 day after VIVITROL injection and then weekly for 4 weeks. Patients will receive ancillary medications as needed and weekly psychosocial intervention. At the end of the study, participants will be offered outpatient treatment of OD at the study site, or will be referred to other treatment programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BUP/VLNXT to VIVITROL | Experimental | Drug: very low dose naltrexone, Drug: extended release naltrexone, Drug: buprenorphine/naloxoneOn days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women 18 to 65 years of age who meet DSM-IV criteria for OD of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
- Individuals must be capable of giving informed consent and capable of complying with study procedures.
- Participants will be asked to provide locator information including the address and telephone number of a non-drug abusing relative or friend who can reach the participant in emergencies.
Key exclusion criteria (11 listed)
- Individuals currently prescribed or regularly taking opiates for chronic pain or medical illness.
- Individuals regularly using licit or illicit methadone or BUP.
- Individuals meeting DSM-IV criteria for schizophrenia, schizoaffective or psychotic disorders, or psychiatric disorder (other than substance abuse) requiring intervention.
- Individuals who are medically unstable, or have liver enzyme function tests greater than two times normal.
- Individuals with current suicidal risk or 1 or more suicide attempts 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 |
|---|---|---|
| very low dose naltrexoneOn days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. | Drug | BUP/VLNXT to VIVITROL |
| extended release naltrexoneAlso: VivitrolOn days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. | Drug | BUP/VLNXT to VIVITROL |
| buprenorphine/naloxoneAlso: SuboxoneOn days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. | Drug | BUP/VLNXT to VIVITROL |
Primary outcome
Retention in Treatment
Time frame: 4 weeks
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks.
9 secondary outcomes
Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)
Time frame: 4 weeks
Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)
Time frame: 4 weeks
Craving
Time frame: 4 weeks
Illicit Drug Use, Measured by Urine Drug Testing
Time frame: 4 weeks
Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire
Time frame: Day 9
Percentage of Participants Who Adhered to Study Visits.
Time frame: baseline to end of study (approximately 40 days)
Percentage of Participants With Adherence to Medication (Naltrexone)
Time frame: Day 1 to Day 8 (+/- 2 days)
Use of Ancillary Medications.
Time frame: baseline to week 1
Number of Participants That Self Reported Illicit Drug Use
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Paolo Mannelli, MD principal investigator
Duke University Health Systems
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 very low dose naltrexone, extended release naltrexone and buprenorphine/naloxone in people with Opiate Dependence, run by Paolo Mannelli 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 3 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: finished, as of the sponsor's last update on 1 Jun 2016. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2016). 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?
Retention in Treatment (time frame: 4 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 1 Jun 2016.