Skip to main content
Journal cover image

Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial.

Publication ,  Journal Article
Bisaga, A; Mannelli, P; Yu, M; Nangia, N; Graham, CE; Tompkins, DA; Kosten, TR; Akerman, SC; Silverman, BL; Sullivan, MA
Published in: Drug Alcohol Depend
June 1, 2018

BACKGROUND: Injectable extended-release naltrexone (XR-NTX), approved to prevent relapse to opioid dependence, requires initial abstinence. This multisite outpatient clinical trial examined the efficacy and safety of low-dose oral naltrexone (NTX), combined with a brief buprenorphine (BUP) taper and standing ancillary medications, for detoxification and induction onto XR-NTX. METHODS: Patients (N = 378) were randomized, stratified by primary short-acting opioid-of-use, to one of three regimens: NTX + BUP; NTX + placebo BUP (PBO-B); placebo NTX (PBO-N) + PBO-B. Patients received 7 days of ascending NTX or placebo, concurrent with a 3-day BUP or placebo taper, and ancillary medications in an outpatient setting. Daily psychoeducational counseling was provided. On Day 8, patients passing a naloxone challenge received XR-NTX. RESULTS: Rates of transition to XR-NTX were comparable across groups: NTX/BUP (46.0%) vs. NTX/PBO-B (40.5%) vs. PBO-N/PBO-B (46.0%). Thus, the study did not meet its primary endpoint. Adverse events, reported by 32.5% of all patients, were mild to moderate in severity and consistent with opioid withdrawal. A first, second, and third XR-NTX injection was received by 44.4%, 29.9%, and 22.5% of patients, respectively. Compared with the PBO-N/PBO-B group, the NTX/BUP group demonstrated higher opioid abstinence during the transition and lower post-XR-NTX subjective opioid withdrawal scores. CONCLUSIONS: A 7-day detoxification protocol with NTX alone or NTX + BUP provided similar rates of induction to XR-NTX as placebo. For those inducted onto XR-NTX, management of opioid withdrawal symptoms prior to induction was achieved in a structured outpatient setting using a well-tolerated, fixed-dose ancillary medication regimen common to all three groups.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Drug Alcohol Depend

DOI

EISSN

1879-0046

Publication Date

June 1, 2018

Volume

187

Start / End Page

171 / 178

Location

Ireland

Related Subject Headings

  • Substance Withdrawal Syndrome
  • Substance Abuse
  • Patient Transfer
  • Outpatients
  • Opioid-Related Disorders
  • Narcotic Antagonists
  • Naltrexone
  • Middle Aged
  • Male
  • Injections, Intramuscular
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Bisaga, A., Mannelli, P., Yu, M., Nangia, N., Graham, C. E., Tompkins, D. A., … Sullivan, M. A. (2018). Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial. Drug Alcohol Depend, 187, 171–178. https://doi.org/10.1016/j.drugalcdep.2018.02.023
Bisaga, Adam, Paolo Mannelli, Miao Yu, Narinder Nangia, Christine E. Graham, D Andrew Tompkins, Thomas R. Kosten, Sarah C. Akerman, Bernard L. Silverman, and Maria A. Sullivan. “Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial.Drug Alcohol Depend 187 (June 1, 2018): 171–78. https://doi.org/10.1016/j.drugalcdep.2018.02.023.
Bisaga A, Mannelli P, Yu M, Nangia N, Graham CE, Tompkins DA, et al. Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial. Drug Alcohol Depend. 2018 Jun 1;187:171–8.
Bisaga, Adam, et al. “Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial.Drug Alcohol Depend, vol. 187, June 2018, pp. 171–78. Pubmed, doi:10.1016/j.drugalcdep.2018.02.023.
Bisaga A, Mannelli P, Yu M, Nangia N, Graham CE, Tompkins DA, Kosten TR, Akerman SC, Silverman BL, Sullivan MA. Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial. Drug Alcohol Depend. 2018 Jun 1;187:171–178.
Journal cover image

Published In

Drug Alcohol Depend

DOI

EISSN

1879-0046

Publication Date

June 1, 2018

Volume

187

Start / End Page

171 / 178

Location

Ireland

Related Subject Headings

  • Substance Withdrawal Syndrome
  • Substance Abuse
  • Patient Transfer
  • Outpatients
  • Opioid-Related Disorders
  • Narcotic Antagonists
  • Naltrexone
  • Middle Aged
  • Male
  • Injections, Intramuscular