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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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.
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.
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.
Duke University Medical Center / Civitan Building
Durham, North Carolina, United States
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.
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
Illicit Drug Use, Measured by Urine Drug Testing
number of participants that tested positive for marijuana, cocaine, and opiates.
Time frame: 4 weeks
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Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire
Questionnaire consisted of 3 questions. 1. Were you satisfied with the treatment (range 1-5): Completely satisfied (1) to completely dissatisfied (5). 2. Were you satisfied with withdrawal treatment (range 1-5): Minimal withdrawal (1) to worse than ever (5). 3. Did the medication help (range 1-5): Helped a lot (1) to No it did not help (5). Lower scores represent greater satisfaction.
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)
Participant who took Naltrexone as prescribed.
Time frame: Day 1 to Day 8 (+/- 2 days)
Use of Ancillary Medications.
Number of participants that took ancillary medication
Time frame: 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
Time frame: 4 weeks