Phase 2
N=38
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
Opioid-related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00637000 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration — 9.1; 10.1; 4.2; 5.7 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Buprenorphine soluble film (Drug); Buprenorphine/naloxone film strip (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indivior Inc.
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration |
9.1; 10.1; 4.2; 5.7 | <0.0001 sig |
| SECONDARY Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at the End of Induction and the Peak COWS Post Induction |
0.6; 1.0; 1.0; 2.6 | 0.000 sig |
| SECONDARY Pupil Diameter Measurements at Baseline and the Maximum Pupil Diameter up to 23.5 Hours After the First Administration |
6.24; 6.11; 4.39; 5.99 | 0.035 sig |
| SECONDARY Pupil Diameter Measurements at Baseline and the Minimum Pupil Diameter up to 23.5 Hours After the First Administration |
6.24; 6.11; 4.39; 4.32 | <0.0001 sig |
| SECONDARY Pupil Diameter Measurements At End of Induction (End of Day 2) and the Minimum Pupil Diameter During the Post Induction Period (Days 3-5) |
5.3; 5.1; 4.1; 3.6 | <0.0001 sig |
| SECONDARY Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "How High Are You?" |
0.0; 0.0; 5.8; 13.7 | 0.006 sig |
| SECONDARY Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Do You Feel Any Drug Effect?" |
0.0; 0.0; 44.3; 50.4 | <0.0001 sig |
| SECONDARY Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Does the Drug Have Any Good Effects?" |
0.0; 0.0; 62.3; 57.6 | <0.0001 sig |
| SECONDARY Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Does the Drug Have Any Bad Effects?" |
0.0; 12.5; 4.4; 6.1 | 0.762 |
| SECONDARY CVisual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Do You Like the Drug?" |
0.0; 0.0; 61.2; 59.4 | <0.0001 sig |
| SECONDARY Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: "Does the Drug Make You Sick?" |
0.0; 12.5; 2.1; 4.5 | 0.349 |
| SECONDARY Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "How High Are You?" |
0.0; 6.3; 8.2; 12.9 | 0.028 sig |
| SECONDARY Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Do You Feel Any Drug Effect?" |
7.9; 15.9; 53.2; 47.4 | <0.0001 sig |
| SECONDARY Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Do You Feel Any Good Effects?" |
11.0; 20.2; 61.7; 52.9 | <0.0001 sig |
| SECONDARY Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Does the Drug Have Any Bad Effects?" |
0.0; 0.3; 0.4; 0.4 | 0.117 |
| SECONDARY Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Do You Like the Drug?" |
14.9; 24.3; 61.7; 55.4 | <0.0001 sig |
| SECONDARY Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: "Does the Drug Make You Sick?" |
0; 0.3; 0; 0.7 | 0.238 |
| SECONDARY Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) |
20; 18; 15; 16; 19; 16 | — |
Summary
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.
Eligibility Criteria
Inclusion Criteria
Subject must:
- Provide written informed consent.
- Have a Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of opioid dependence.
- Be male or female, 18 to 65 years of age, inclusive.
- If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control.
Exclusion Criteria
Subjects must not:
- Have participated in an experimental drug or device study within the last 30 days.
- Be currently (past 30 days from start of screening) engaged in opioid agonist, opioid partial agonist, or opioid antagonist treatment.
- If female, be breast feeding or lactating.
- Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study.
- Have any clinically significant non-substance use psychiatric disorder (e.g., schizophrenia).
- Have current suicidal ideation.
- Have a Mini Mental Status Exam score less than 24.
- Have physical dependence on alcohol.
- Have physical dependence on sedative-hypnotics.
- Have active aphthous stomatitis.
- Have active oral herpes.
- Need on-going prescription medications that interact with the P450 3A4 (a member of the cytochrome P450 superfamily of enzymes) system.
Data sourced from ClinicalTrials.gov (NCT00637000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.