Trial Outcomes & Findings for Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence (NCT NCT01690546)

NCT ID: NCT01690546

Last Updated: 2016-06-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 38 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2016-06-01

Participant Flow

38 participants signed consent. 3 participants were screen failures. 35 participants started study.

Participant milestones

Measure	BUP/VLNXT to VIVITROL
Overall Study STARTED	35
Overall Study Extended Release Injectable NTX	27
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence

Baseline characteristics by cohort

Measure	BUP/VLNXT to VIVITROL n=35 Participants
Age, Continuous	40.1 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race/Ethnicity, Customized African American	26 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	9 participants n=5 Participants
Years of Opioid use	9.7 years n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: All participants who received the Extended Release Injectable NTX

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.

Outcome measures

Measure	BUP/VLNXT to VIVITROL n=27 Participants
Retention in Treatment	26 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: All participants who received the Extended Release Injectable NTX

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.

Outcome measures

Measure	BUP/VLNXT to VIVITROL n=27 Participants
Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)	0.64 units on a scale Standard Deviation 1.29

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BUP/VLNXT to VIVITROL n=27 Participants
Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)	1.52 units on a scale Standard Deviation 3.19

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BUP/VLNXT to VIVITROL n=27 Participants
Craving	5.12 units on a scale Standard Deviation 14.41

SECONDARY outcome

Timeframe: 4 weeks

number of participants that tested positive for marijuana, cocaine, and opiates.

Outcome measures

Measure	BUP/VLNXT to VIVITROL n=26 Participants
Illicit Drug Use, Measured by Urine Drug Testing Marijuana	11 participants
Illicit Drug Use, Measured by Urine Drug Testing Cocaine	3 participants
Illicit Drug Use, Measured by Urine Drug Testing Opiates	4 participants

SECONDARY outcome

Timeframe: Day 9

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.

Outcome measures

Measure	BUP/VLNXT to VIVITROL n=27 Participants
Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire Were you satisfied with the treatment	1.31 units on a scale Standard Deviation 0.84
Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire Were you satisfied with withdrawal treatment	2.04 units on a scale Standard Deviation 0.82
Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire Did the medication help	1.69 units on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: baseline to end of study (approximately 40 days)

Outcome measures

Measure	BUP/VLNXT to VIVITROL n=35 Participants
Percentage of Participants Who Adhered to Study Visits.	74 percentage of participants

SECONDARY outcome

Timeframe: Day 1 to Day 8 (+/- 2 days)

Participant who took Naltrexone as prescribed.

Outcome measures

Measure	BUP/VLNXT to VIVITROL n=35 Participants
Percentage of Participants With Adherence to Medication (Naltrexone)	100 percentage of participants

SECONDARY outcome

Timeframe: baseline to week 1

Number of participants that took ancillary medication

Outcome measures

Measure	BUP/VLNXT to VIVITROL n=35 Participants
Use of Ancillary Medications.	35 participants

SECONDARY outcome

Timeframe: 4 weeks

Participants reported on any illicit drug use to include Cocaine marijuana opiates

Outcome measures

Measure	BUP/VLNXT to VIVITROL n=26 Participants
Number of Participants That Self Reported Illicit Drug Use Marijuana	10 participants
Number of Participants That Self Reported Illicit Drug Use Cocaine	3 participants
Number of Participants That Self Reported Illicit Drug Use Opiates	4 participants

Adverse Events

BUP/VLNXT to VIVITROL

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	BUP/VLNXT to VIVITROL n=35 participants at risk
Psychiatric disorders persecutory ideations	2.9% 1/35

Other adverse events

Measure	BUP/VLNXT to VIVITROL n=35 participants at risk
General disorders Increased Withdrawal Symptoms	17.1% 6/35

Additional Information

Paolo Mannelli, M.D

Duke University Medical Center

Phone: 919-681-0613

Email: paolo.mannelli@dm.duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place