Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence (BUP/NXT-VIVI)
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| ClinicalTrials.gov Identifier: NCT01690546 |
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Recruitment Status :
Completed
First Posted : September 21, 2012
Results First Posted : June 1, 2016
Last Update Posted : June 1, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Opiate Dependence | Drug: very low dose naltrexone Drug: extended release naltrexone Drug: buprenorphine/naloxone | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 38 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction |
| Study Start Date : | September 2012 |
| Actual Primary Completion Date : | February 2015 |
| Actual Study Completion Date : | February 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: BUP/VLNXT to 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.
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Drug: very low dose naltrexone
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. Drug: extended release naltrexone 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.
Other Name: Vivitrol Drug: buprenorphine/naloxone 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.
Other Name: Suboxone |
- 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.
- Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS) [ 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 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.
- Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS) [ 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 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.
- Craving [ Time Frame: 4 weeks ]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.
- Illicit Drug Use, Measured by Urine Drug Testing [ Time Frame: 4 weeks ]number of participants that tested positive for marijuana, cocaine, and opiates.
- Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire [ Time Frame: Day 9 ]
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.
- 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) ]Participant who took Naltrexone as prescribed.
- Use of Ancillary Medications. [ Time Frame: baseline to week 1 ]Number of participants that took ancillary medication
- Number of Participants That Self Reported Illicit Drug Use [ Time Frame: 4 weeks ]Participants reported on any illicit drug use to include Cocaine marijuana opiates
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690546
| United States, North Carolina | |
| Duke University Medical Center / Civitan Building | |
| Durham, North Carolina, United States, 27705 | |
| Principal Investigator: | Paolo Mannelli, MD | Duke University Health Systems |
| Responsible Party: | Paolo Mannelli, Associate Professor of Psychiatry, Duke University |
| ClinicalTrials.gov Identifier: | NCT01690546 |
| Other Study ID Numbers: |
Pro00036909 |
| First Posted: | September 21, 2012 Key Record Dates |
| Results First Posted: | June 1, 2016 |
| Last Update Posted: | June 1, 2016 |
| Last Verified: | April 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Opioid Addiction Addiction Drug Dependence |
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Opioid-Related Disorders Narcotic-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Naltrexone Buprenorphine Buprenorphine, Naloxone Drug Combination Naloxone |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists Alcohol Deterrents |