A 24-week, multicenter, double-blind, randomized, placebo-controlled trial of opioid-dependent (DSM-IV) outpatients, ≥18 years of age1,2
PIVOTAL STUDY DATA1,2
- Prior to treatment initiation, patients were voluntarily seeking treatment, completing ≤30 days of inpatient opioid detoxification and not taking opioids for at least 7 days
Participants were randomized to receive VIVITROL (n=126) or placebo (n=124)
- Every week—urine drug test
- Every 2 weeks—psychosocial support
- Every 4 weeks—treatment injection
OPIOID STUDY DESIGN1
After randomization, there was a 4-week period for treatment engagement during which opioid use, if it occurred, was allowed. This period was not included in the analysis. Subjects provided additional self-report of opioid use.
- Past/present history of an AIDS-indicator disease
- Evidence of hepatic failure
- Active hepatitis and/or aspartate aminotransferase or alanine aminotransferase >3 times the upper limit of normal
THE EFFICACY OF VIVITROL1
Response profile of patients who achieved complete abstinence during Weeks 5–24
- Complete abstinence or "opioid-free" was defined as a negative urine drug test for opioids and no self-reported opioid use
- Weeks 1-4 were omitted from this endpoint to allow for stabilization of abstinence
- Self-reported opioid-free days
- Craving scores
- Treatment retention days
- Relapse to physiological opioid dependence
DEMOGRAPHICS AND CLINICAL BASELINE CHARACTERISTICS
|Age in years||29.4 (±4.8)||29.7 (±3.6)|
|Men||113 (90%)||107 (86%)|
|White||124 (98%)||124 (100%)|
|Duration of opioid dependence in years||9.1 (±4.5)||10.0 (±3.9)|
|Days of pre-study inpatient detoxification||18 (±9)||18 (±7)|
|Opioid craving scale||18 (±23)||22 (±24)|
|HIV serology positive||51 (40%)||52 (42%)|
|Hepatitis C positive||111 (88%)||117 (94%)|
Data are mean (standard deviation [SD]) or number (%)
COMPLETE OPIOID ABSTINENCE1,2*
With VIVITROL and counseling, more patients achieved complete abstinence vs placebo.
- Complete abstinence was sustained by 36% of VIVITROL patients (n=45) compared with 23% of patients treated with placebo (n=28), during Weeks 5-24 (P=0.0224)
SUBJECTS SUSTAINING VARYING PERCENTAGES OF OPIOID-FREE WEEKS
- The median of the VIVITROL group had confirmed abstinence* for 90% of the weeks in the evaluation period vs 35% for the median of the placebo group
*Complete or confirmed abstinence was defined as a negative urine drug test for opioids and no self-reported opioid use. †Psychosocial support consisted of bi-weekly counseling sessions of individual drug counseling, adapted for opioid dependence. Data were not collected during Weeks 1-4 of the trial to allow for stabilization of abstinence.
SELF-REPORTED OPIOID-FREE‡ DAYS
Patients treated with VIVITROL and counseling had 99.2% opioid-free days1
- The median of the VIVITROL group reported 99.2% opioid-free days compared with 60.4% in the placebo group1
- The median number of opioid-free days at baseline was zero for both the VIVITROL and placebo groups3
THE MEDIAN OF THE VIVITROL GROUP HAD 99.2%
OPIOID-FREE DAYS DURING WEEKS 1–241
‡"Opioid-free" was defined as no self-reported opioid use. §Psychosocial support consisted of bi-weekly counseling sessions of individual drug counseling, adapted for opioid dependence.
SECONDARY ENDPOINT: CRAVING
In a pivotal trial, patients treated with VIVITROL experienced a reduction in opioid craving vs placebo.1
- Craving (described as a "need for opioids") was reported weekly according to a visual analogue scale (VAS) of 0–100, with 0 being “none” and 100 "very much so"1
- A statistically and clinically significant reduction in opioid craving was observed with VIVITROL vs placebo by Week 8 (P=0.0048), which persisted every week through Week 24 (P<0.0001, adjusted)1
- Patients treated with VIVITROL had an average 10.1 decrease in baseline craving as measured by the VAS score, while patients who received placebo had a 0.7 increase in baseline craving as measured by VAS score (P<0.0001, adjusted)1
MEAN CHANGE IN SELF-REPORTED CRAVING1,3
Change in Mean Craving Score3
- VIVITROL: 55% lower mean craving score at 24 weeks compared to baseline
- Placebo: 3% higher mean craving score at 24 weeks compared to baseline
IIPsychosocial support consisted of bi-weekly counseling sessions of individual drug counseling, adapted for opioid dependence.
Among opioid-dependent patients treated with VIVITROL and counseling, median time in treatment was 1.7x longer than with placebo.
- Patients receiving VIVITROL were significantly more likely to complete 6 months of treatment (n=67, 53%) compared with those receiving placebo (n=47, 38%; P=0.0171)
At the end of the study period (168 days), the median of the VIVITROL group had not dropped out1
- The median time in treatment was >168 days for VIVITROL patients vs 96 days with placebo
THE MEDIAN OF THE VIVITROL GROUP HAD LONGER TREATMENT RETENTION VS PLACEBO
¶Psychosocial support consisted of bi-weekly counseling sessions of individual drug counseling, adapted for opioid dependence.
SECONDARY ENDPOINT: RELAPSE TO PHYSIOLOGICAL OPIOID DEPENDENCE
Only 1 patient on VIVITROL (<1%) discontinued due to positive naloxone challenge, indicating physical dependence had been re-established, compared to 17 patients on placebo (14%)1
94% fewer naloxone-confirmed
relapses to dependence.1
ADVERSE REACTIONS IN OPIOID-DEPENDENCE CLINICAL STUDIES2
Adverse reactions that occurred in ≥2% of patients with opioid dependence treated with VIVITROL and occurred more frequently in the VIVITROL group vs the placebo group.
|VIVITROL 380 mg with
|Alanine aminotransferase increased||13%||6%|
|Aspartate aminotransferase increased||10%||2%|
|Injection site pain||5%||1%|
Please see complete list of adverse events in the VIVITROL Prescribing Information.
Discontinuation rates due to adverse events were similar in opioid-dependent patients treated with VIVITROL vs patients treated with placebo.DOWNLOAD THE VIVITROL BROCHURE TO DISCUSS WITH YOUR PATIENTS
The X:BOT study, “Comparative Effectiveness of Extended-Release Naltrexone Versus Buprenorphine-Nalaxone for Opioid Relapse Prevention,” provides additional useful information. Read about it now
VIVITROL is not right for everyone. There are significant risks from VIVITROL treatment, including risk of opioid overdose, injection site reactions and sudden opioid withdrawal.
See Important Safety Information below. Discuss all benefits and risks with your patients. See Prescribing Information and Medication Guide with your patients.