Effectiveness of injectable extended-release naltrexone vs daily buprenorphine-naloxone for opioid dependence1
Tanum study design1
- A Norway-based, 12-week, open-label, randomized clinical trial in which patients recruited from outpatient addiction clinics and detoxification units were randomized to oral BUP-NX (n=79) or XR-NTX (n=80) after detoxification. Participants were asked to attend standard drug counseling, but no behavioral interventions could be initiated
participate (51), not meeting inclusion criteria (9),
failing detoxification (6), or other reasons (7).
Demographics and clinical baseline characteristics1
|ITT POPULATION (n=159)|
|Lifetime Characteristic||XR-NTX† (n=80)||BUP-NX† (n=79)|
|Age, mean (SD), years||36.4 (8.8)||35.7 (8.5)|
|Male, n (%)||61 (76.3)||54 (68.4)|
|White, n (%)||72 (90.0)||70 (88.6)|
|Injecting (intravenous) users, n (%)||72 (90.0)||64 (81.0)|
|HIV positive, n (%)||2 (2.5)||2 (2.5)|
|Hepatitis C seropositive, n (%)||44 (55.0)||42 (53.2)|
|Years of substance use, mean (SD)|
|Heavy opioid use||8.9 (7.8)||9.6 (10.5)|
|Heroin||6.9 (5.8)||6.7 (5.2)|
|Other illicit opioids||2.4 (5.1)||3.2 (7.0)|
|Use during past 30 days (baseline), mean (SD)|
|Heroin||7.6 (11.0)||12.0 (12.9)|
|Other illicit opioids||8.2 (11.1)||14.5 (13.2)|
- The number of days of use of heroin and other illicit opioids
- Trial completion rate
- Proportion of illicit opioid-negative UDTs†
DAYS OF USE OF HEROIN AND OTHER ILLICIT OPIOIDS FOR XR-NTX VS BUP-NX1
XR-NTX was noninferior to BUP-NX in helping opioid-dependent patients decrease the number of days in which they used heroin and other illicit opioids
- Mean 3.2 fewer days of heroin use (95% CI, -4.9 to -1.5)
- Mean 2.7 fewer days of other illicit opioids use (95% CI, -4.6 to -0.9)
Retention time on XR-NTX vs BUP-NX at the conclusion of the 12-week study
Illicit opioid-negative UDTs
Mean (SD), 0.9 (0.3) and 0.8 (0.4), respectively; mean difference, 0.1 with 95% CI, -0.04 to 0.2
The study was not blinded. Participants in each treatment group knew which medication they were receiving during the trial.
- For the study to have been blinded, it would have required placebo injections like the XR-NTX kits or placebo tablets for BUP-NX
- Patients would be able to determine their respective treatment quite quickly, given their long experience with opioid use
- Due to an increased risk of overdose in newly detoxified opioid users, the use of placebo and the masking of medications were considered unethical
Funding/Support: The study was supported by unrestricted grants from the Research Council of Norway and the Western Norway Regional Health Authority. Financial support was also received from the Norwegian Centre for Addiction Research, University of Oslo, and from Akershus University Hospital.
Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication; however, Alkermes, Inc. was allowed to comment on the manuscript before submission for publication.
Alkermes, Inc. supplied extended-release naltrexone for the study.
View the open-label, head-to-head study in the treatment of opioid dependence.
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Reference: 1. Tanum L, Solli KK, Latif ZE, et al. Effectiveness of injectable extended-release naltrexone vs daily buprenorphine-naloxone for opioid dependence: a randomized clinical noninferiority trial. JAMA Psychiatry. 2017;74(12):1197-1205.
‡Terms and Conditions
Eligibility for Alkermes-Sponsored Co-pay Savings. This offer is only available to patients 18 years or older, with a prescription consistent with the Prescribing Information and the patient is not enrolled in, or covered by, any local, state, federal or other government program that pays for any portion of medication costs, including but not limited to Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care and Alternative Benefit Plans under the Affordable Care Act; Medigap; VA; DOD; TRICARE; or a residential correctional program.