Opioid Dependence, on Agonist Therapy
Conditions
Keywords
Opioid, Dependence, agonist, buprenorphine, naloxone, BUP/NAL
Brief summary
The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.
Detailed description
This prospective, randomized, multicenter, parallel-group, non-inferiority study was conducted at 43 centers in the United States from August 2013 to April 2014. A non-inferior design was used because both products contain the same active components, and it was considered unethical to include a placebo arm. The study comprised an induction phase of 2 days and a stabilization phase of 20 days, with study visits scheduled on Days 1, 2, 3, 4, 8, 15, and 22. Eligible opioid-dependent patients were randomly assigned within 14 days of screening to induction with either the BNX sublingual tablets or generic buprenorphine tablets for 2 days. On Day 3, patients initially allocated to buprenorphine were switched to BNX film, whereas those allocated to BNX sublingual tablets continued on the same treatment. On Day 15, patients receiving BNX film were switched to BNX sublingual tablets, and those on BNX sublingual tablets were switched to BNX film. At the final study visit on Day 22, patients were offered the option of continuing in an open-label follow-up study of BNX sublingual tablets.
Interventions
DRUGBNX sublingual tablets
Buprenorphine/naloxone sublingual tablets
DRUGBNX sublingual film
Buprenorphine/naloxone sublingual film
DRUGBuprenorphine
Buprenorphine sublingual tablets
Sponsors
Worldwide Clinical Trials
Orexo AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male/female 18-65 years old 2. Able to read, comprehend & sign the informed consent form 3. Meet opioid dependence criteria in DSM-IV-TR the past 12 months 4. Have a buprenorphine-negative UDS &/or urine dipstick 5. Prepared to abstain from opioids other than the study drug & from other addictive drugs 6. Negative urine pregnancy test 7. Females of childbearing potential who use a reliable method of contraception. Females of non-childbearing potential; surgically sterile or post-menopausal as defined by being at least 50 years of age & having an absence of menses for at least 2 years 8. Clearance from the prescribing MD to be withdrawn from their prescribed opioids for subjects receiving opioids for pain 9. Lack of clinically significant abnormalities in health assessments performed at screening. Unclear cases should be approved by the medical monitor 10. At least mild withdrawal symptoms (COWS ≥9)
Exclusion criteria
1. Pregnant, lactating or planning to be pregnant during study 2. Unwilling/unable to comply with the requirements of the protocol (e.g., pending incarceration) are in a situation/condition that may interfere with participation in the study 3. Prescribed treatment with generic buprenorphine monotherapy within 90 days prior start of treatment 4. Daily dose of methadone over 30 mg during the past week or who received the last dose of methadone less than 30 hours prior to treatment 5. Participating in other clinical studies in which medications is delivered or who have used an investigational drug/device within the last 30 days 6. Allergy, sensitivity or intolerance to BUP, NAL or any related drug; history of drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject/study 7. Staff, affiliated with, or family member of the staff directly involved with this study 8. Serious untreated Axis I DSM-IV-TR psychiatric comorbidity (actively suicidal or homicidal, have untreated schizophrenia) 9. Tongue/oral deformities that may affect the absorption of the drug products 10. Current/history of clinically significant medical disorder or condition which would jeopardize the safety or impact the validity of the results. Unclear cases should be discussed with & approved by the medical monitor 11. HIV-seropositive with a CD4+ count \<200, active AIDS defining infection in the last 120 days 12. Have Class III/IV congestive heart failure, symptomatic myocardial ischemia or history of long QT syndrome (or an immediate family member with this condition) 13. Currently taking Class 1A antiarrhythmic medications (e.g., quinidine, procainamide, & disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, & dofetilide) 14. Have uncontrolled hypertension, pulse oximetry ≤92%or clinically significant abnormality on 12-lead ECG, including a corrected QT (QTc) interval \>450 ms 15. Severe liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoints of Retention in Treatment at Days 3 and 15 | Day 3 and Day 15 | Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COWS Total Scores: Stabilization/Maintenance | Days 3 through 22 | Absolute ± mean standard deviation values for COWS total scores at Days 3, 4, 8, 15, and 22; COWS scores range from 0-48, with a lower score being more favorable |
| Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Days 1 and 2 | Absolute ± mean standard deviation values for SOWS total scores at baseline, 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; SOWS score ranges from 0-64, with a lower score being more favorable |
| Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Days 1 and 2 | Absolute ± mean standard deviation values for COWS total scores at baseline; 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; COWS scores range from 0-48, with a lower score being more favorable |
| Visual Analog Scale (VAS) Cravings: Induction | Days 1 and 2 | Absolute mean ± standard deviation values for VAS cravings at baseline, 0.5 h, 1.5 h, 3 h, and 6 post dose on Day 1, and Day 2; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had) |
| VAS Craving Scores: Stabilization/Maintenance | Days 3 through 22 | Absolute mean ± standard deviation values for VAS cravings scores on Days 3, 4, 8, 15, and 22; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had) |
| SOWS Total Scores: Stabilization/Maintenance | Days 3 through 22 | Absolute ± mean standard deviation values for SOWS total scores on Days 2, 3, 4, 8, 15, and 22; SOWS scores ranged from 0-64, with a lower score being more favorable |
Countries
United States
Participant flow
Pre-assignment details
A total of 759 patients were enrolled. One patient who was randomized did not receive study drug, making the participant flow total 758.
Participants by arm
| Arm | Count |
|---|---|
| BNX Tablets, Then OL BNX Tablets, Then BNX Film Days 1-2: BNX sublingual tablets (blinded); Days 3-14: BNX sublingual tablets (open-label); Days 15-21: Switch to BNX sublingual film (open-label); Day 22: End of study visit | 383 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets Days 1-2: Generic buprenorphine sublingual tablets (blinded); Days 3 to 14: BNX sublingual film (open-label); Days 15-21: Switch to BNX sublingual tablets (open-label); Day 22: End of study visit | 375 |
| Total | 758 |
Baseline characteristics
| Characteristic | Buprenorphine, Then OL BNX Film, Then BNX Tablets | Total | BNX Tablets, Then OL BNX Tablets, Then BNX Film |
|---|---|---|---|
| Age, Continuous | 35.7 years STANDARD_DEVIATION 11.3 | 35.6 years STANDARD_DEVIATION 11.3 | 35.6 years STANDARD_DEVIATION 11.3 |
| Body mass index | 26.3 kg/m2 STANDARD_DEVIATION 5.7 | 26.3 kg/m2 STANDARD_DEVIATION 5.8 | 26.2 kg/m2 STANDARD_DEVIATION 5.9 |
| Duration of opioid use | 10.5 years STANDARD_DEVIATION 9 | 10.6 years STANDARD_DEVIATION 9.3 | 10.7 years STANDARD_DEVIATION 9.6 |
| Height | 172.3 cm STANDARD_DEVIATION 9.4 | 171.9 cm STANDARD_DEVIATION 9.4 | 171.5 cm STANDARD_DEVIATION 9.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 100 Participants | 51 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) White | 312 Participants | 630 Participants | 318 Participants |
| Sex: Female, Male Female | 139 Participants | 306 Participants | 167 Participants |
| Sex: Female, Male Male | 236 Participants | 452 Participants | 216 Participants |
| Weight | 78.3 kg STANDARD_DEVIATION 18.4 | 77.7 kg STANDARD_DEVIATION 18.6 | 77.1 kg STANDARD_DEVIATION 18.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 61 / 383 | 55 / 375 |
| serious Total, serious adverse events | 3 / 383 | 1 / 375 |
Outcome results
Primary
Primary Endpoints of Retention in Treatment at Days 3 and 15
Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.
Time frame: Day 3 and Day 15
Population: Per protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Primary Endpoints of Retention in Treatment at Days 3 and 15 | Retention at Day 3 | 309 participants |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Primary Endpoints of Retention in Treatment at Days 3 and 15 | Retention at Day 15 | 273 participants |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Primary Endpoints of Retention in Treatment at Days 3 and 15 | Retention at Day 15 | 269 participants |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Primary Endpoints of Retention in Treatment at Days 3 and 15 | Retention at Day 3 | 302 participants |
Secondary
Clinical Opiate Withdrawal Scale (COWS) Scores: Induction
Absolute ± mean standard deviation values for COWS total scores at baseline; 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; COWS scores range from 0-48, with a lower score being more favorable
Time frame: Days 1 and 2
Population: Full Analysis Population - number of enrolled patients at the beginning of the measurement period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Baseline | 15.0 units on a scale | Standard Deviation 4.2 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Day 1 0.5 h post dose | 10.5 units on a scale | Standard Deviation 4.6 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Day 1 1.5 h post dose | 8.8 units on a scale | Standard Deviation 4.6 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Day 1 3 h post dose | 6.6 units on a scale | Standard Deviation 5.1 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Day 1 6 h post dose | 5.3 units on a scale | Standard Deviation 4.1 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Day 2 | 8.0 units on a scale | Standard Deviation 4.9 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Day 1 6 h post dose | 5.4 units on a scale | Standard Deviation 4.6 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Baseline | 14.9 units on a scale | Standard Deviation 4.3 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Day 1 3 h post dose | 6.1 units on a scale | Standard Deviation 5.1 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Day 1 0.5 h post dose | 10.3 units on a scale | Standard Deviation 4.7 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Day 2 | 7.6 units on a scale | Standard Deviation 5.2 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Day 1 1.5 h post dose | 8.3 units on a scale | Standard Deviation 4.5 |
Secondary
COWS Total Scores: Stabilization/Maintenance
Absolute ± mean standard deviation values for COWS total scores at Days 3, 4, 8, 15, and 22; COWS scores range from 0-48, with a lower score being more favorable
Time frame: Days 3 through 22
Population: Full analysis population - - number of enrolled patients at the beginning of the measurement period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | COWS Total Scores: Stabilization/Maintenance | Day 4 | 5.2 units on a scale | Standard Deviation 4 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | COWS Total Scores: Stabilization/Maintenance | Day 15 | 4.1 units on a scale | Standard Deviation 3.5 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | COWS Total Scores: Stabilization/Maintenance | Day 8 | 4.8 units on a scale | Standard Deviation 3.9 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | COWS Total Scores: Stabilization/Maintenance | Day 22: Film (col 1); Tablets (col 2) | 3.4 units on a scale | Standard Deviation 3.3 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | COWS Total Scores: Stabilization/Maintenance | Day 3 | 6.0 units on a scale | Standard Deviation 4.2 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | COWS Total Scores: Stabilization/Maintenance | Day 22: Film (col 1); Tablets (col 2) | 3.3 units on a scale | Standard Deviation 3.4 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | COWS Total Scores: Stabilization/Maintenance | Day 3 | 5.9 units on a scale | Standard Deviation 4.4 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | COWS Total Scores: Stabilization/Maintenance | Day 4 | 5.1 units on a scale | Standard Deviation 4.3 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | COWS Total Scores: Stabilization/Maintenance | Day 8 | 4.6 units on a scale | Standard Deviation 3.9 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | COWS Total Scores: Stabilization/Maintenance | Day 15 | 3.7 units on a scale | Standard Deviation 3.4 |
Secondary
SOWS Total Scores: Stabilization/Maintenance
Absolute ± mean standard deviation values for SOWS total scores on Days 2, 3, 4, 8, 15, and 22; SOWS scores ranged from 0-64, with a lower score being more favorable
Time frame: Days 3 through 22
Population: Full Analysis Population - number of enrolled patients at the beginning of the measurement period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | SOWS Total Scores: Stabilization/Maintenance | Day 4 | 10.1 units on a scale | Standard Deviation 9.2 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | SOWS Total Scores: Stabilization/Maintenance | Day 15 | 7.2 units on a scale | Standard Deviation 7.7 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | SOWS Total Scores: Stabilization/Maintenance | Day 8 | 9.0 units on a scale | Standard Deviation 9.2 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | SOWS Total Scores: Stabilization/Maintenance | Day 22: Film (col 1); Tablets (col 2) | 6.8 units on a scale | Standard Deviation 7.9 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | SOWS Total Scores: Stabilization/Maintenance | Day 3 | 11.9 units on a scale | Standard Deviation 10.4 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | SOWS Total Scores: Stabilization/Maintenance | Day 22: Film (col 1); Tablets (col 2) | 7.3 units on a scale | Standard Deviation 9.2 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | SOWS Total Scores: Stabilization/Maintenance | Day 3 | 12.6 units on a scale | Standard Deviation 11.2 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | SOWS Total Scores: Stabilization/Maintenance | Day 4 | 10.2 units on a scale | Standard Deviation 10.3 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | SOWS Total Scores: Stabilization/Maintenance | Day 8 | 8.8 units on a scale | Standard Deviation 9.6 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | SOWS Total Scores: Stabilization/Maintenance | Day 15 | 6.7 units on a scale | Standard Deviation 8.1 |
Secondary
Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction
Absolute ± mean standard deviation values for SOWS total scores at baseline, 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; SOWS score ranges from 0-64, with a lower score being more favorable
Time frame: Days 1 and 2
Population: Full analysis population - number of enrolled patients at the beginning of the measurement period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Baseline | 31.7 units on a scale | Standard Deviation 13.5 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Day 1 0.5 h post dose | 22.7 units on a scale | Standard Deviation 13.9 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Day 1 1.5 h post dose | 19.1 units on a scale | Standard Deviation 13.5 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Day 1 3 h post dose | 13.6 units on a scale | Standard Deviation 12.7 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Day 1 6 h post dose | 10.7 units on a scale | Standard Deviation 10.2 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Day 2 | 16.7 units on a scale | Standard Deviation 12.3 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Day 1 6 h post dose | 11.1 units on a scale | Standard Deviation 11.8 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Baseline | 33.0 units on a scale | Standard Deviation 13.2 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Day 1 3 h post dose | 13.0 units on a scale | Standard Deviation 12.5 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Day 1 0.5 h post dose | 23.0 units on a scale | Standard Deviation 13.6 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Day 2 | 16.4 units on a scale | Standard Deviation 13.4 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Day 1 1.5 h post dose | 17.8 units on a scale | Standard Deviation 13 |
Secondary
VAS Craving Scores: Stabilization/Maintenance
Absolute mean ± standard deviation values for VAS cravings scores on Days 3, 4, 8, 15, and 22; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)
Time frame: Days 3 through 22
Population: Full analysis population - number of enrolled patients at the beginning of the measurement period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | VAS Craving Scores: Stabilization/Maintenance | Day 4 | 29.1 units on a scale | Standard Deviation 26.2 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | VAS Craving Scores: Stabilization/Maintenance | Day 15 | 21.6 units on a scale | Standard Deviation 23.9 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | VAS Craving Scores: Stabilization/Maintenance | Day 8 | 26.2 units on a scale | Standard Deviation 26.5 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | VAS Craving Scores: Stabilization/Maintenance | Day 22: Film (col 1); Tablets (col 2) | 20.2 units on a scale | Standard Deviation 22.9 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | VAS Craving Scores: Stabilization/Maintenance | Day 3 | 33.7 units on a scale | Standard Deviation 27 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | VAS Craving Scores: Stabilization/Maintenance | Day 22: Film (col 1); Tablets (col 2) | 20.9 units on a scale | Standard Deviation 23.8 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | VAS Craving Scores: Stabilization/Maintenance | Day 3 | 34.5 units on a scale | Standard Deviation 28.2 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | VAS Craving Scores: Stabilization/Maintenance | Day 4 | 28.5 units on a scale | Standard Deviation 26.4 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | VAS Craving Scores: Stabilization/Maintenance | Day 8 | 23.7 units on a scale | Standard Deviation 24.7 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | VAS Craving Scores: Stabilization/Maintenance | Day 15 | 19.1 units on a scale | Standard Deviation 23.4 |
Secondary
Visual Analog Scale (VAS) Cravings: Induction
Absolute mean ± standard deviation values for VAS cravings at baseline, 0.5 h, 1.5 h, 3 h, and 6 post dose on Day 1, and Day 2; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)
Time frame: Days 1 and 2
Population: Full Analysis Population - number of enrolled patients at the beginning of the measurement period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Visual Analog Scale (VAS) Cravings: Induction | Day 1 0.5 h post dose | 56.8 units on a scale | Standard Deviation 26.5 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Visual Analog Scale (VAS) Cravings: Induction | Day 1 3 h post dose | 36.0 units on a scale | Standard Deviation 28.2 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Visual Analog Scale (VAS) Cravings: Induction | Baseline | 69.2 units on a scale | Standard Deviation 23.5 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Visual Analog Scale (VAS) Cravings: Induction | Day 1 6 h post dose | 30.2 units on a scale | Standard Deviation 26.2 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Visual Analog Scale (VAS) Cravings: Induction | Day 2 | 45.3 units on a scale | Standard Deviation 28.7 |
| BNX Tablets, Then OL BNX Tablets, Then BNX Film | Visual Analog Scale (VAS) Cravings: Induction | Day 1 1.5 h post dose | 49.2 units on a scale | Standard Deviation 28.9 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Visual Analog Scale (VAS) Cravings: Induction | Day 2 | 44.9 units on a scale | Standard Deviation 28.4 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Visual Analog Scale (VAS) Cravings: Induction | Baseline | 71.9 units on a scale | Standard Deviation 22 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Visual Analog Scale (VAS) Cravings: Induction | Day 1 0.5 h post dose | 58.2 units on a scale | Standard Deviation 26.4 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Visual Analog Scale (VAS) Cravings: Induction | Day 1 1.5 h post dose | 48.8 units on a scale | Standard Deviation 27.9 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Visual Analog Scale (VAS) Cravings: Induction | Day 1 3 h post dose | 34.9 units on a scale | Standard Deviation 27.8 |
| Buprenorphine, Then OL BNX Film, Then BNX Tablets | Visual Analog Scale (VAS) Cravings: Induction | Day 1 6 h post dose | 29.6 units on a scale | Standard Deviation 26.9 |