Naltrexone for Nonsuicidal Self-Injury

Summary

This randomized, double-blinded, placebo-controlled clinical trial aims to evaluate the efficacy and safety of naltrexone in reducing nonsuicidal self-injurious behavior among individuals with nonsuicidal self-injury. Participants will be randomly assigned to receive either naltrexone plus treatment as usual or placebo plus treatment as usual for 6 weeks. The primary objective is to determine whether naltrexone reduces the frequency of nonsuicidal self-injurious behavior compared with placebo. Secondary objectives include evaluating changes in clinical severity, suicidal ideation, self-injury-related urges, ecological momentary assessment measures, and safety outcomes.

Timeline

Start

2026-06

Primary completion

2027-12

Completion

2028-06

Publications

• Results Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
• Results Bradburn NM, Rips LJ, Shevell SK. Answering autobiographical questions: the impact of memory and inference on surveys. Science. 1987 Apr 10;236(4798):157-61. doi: 10.1126/science.3563494.
• Results Clark DM, Teasdale JD. Diurnal variation in clinical depression and accessibility of memories of positive and negative experiences. J Abnorm Psychol. 1982 Apr;91(2):87-95. doi: 10.1037//0021-843x.91.2.87. No abstract available.
• Results Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
• Results Sonne S, Rubey R, Brady K, Malcolm R, Morris T. Naltrexone treatment of self-injurious thoughts and behaviors. J Nerv Ment Dis. 1996 Mar;184(3):192-5. doi: 10.1097/00005053-199603000-00011. No abstract available.
• Results Casner JA, Weinheimer B, Gualtieri CT. Naltrexone and self-injurious behavior: a retrospective population study. J Clin Psychopharmacol. 1996 Oct;16(5):389-94. doi: 10.1097/00004714-199610000-00008.
• Results Buzan RD, Thomas M, Dubovsky SL, Treadway J. The use of opiate antagonists for recurrent self-injurious behavior. J Neuropsychiatry Clin Neurosci. 1995 Fall;7(4):437-44. doi: 10.1176/jnp.7.4.437.
• Results Kars H, Broekema W, Glaudemans-van Gelderen I, Verhoeven WM, van Ree JM. Naltrexone attenuates self-injurious behavior in mentally retarded subjects. Biol Psychiatry. 1990 Apr 1;27(7):741-6. doi: 10.1016/0006-3223(90)90589-t.
• Results McCauley E, Berk MS, Asarnow JR, Adrian M, Cohen J, Korslund K, Avina C, Hughes J, Harned M, Gallop R, Linehan MM. Efficacy of Dialectical Behavior Therapy for Adolescents at High Risk for Suicide: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Aug 1;75(8):777-785. doi: 10.1001/jamapsychiatry.2018.1109.
• Results Mehlum L, Tormoen AJ, Ramberg M, Haga E, Diep LM, Laberg S, Larsson BS, Stanley BH, Miller AL, Sund AM, Groholt B. Dialectical behavior therapy for adolescents with repeated suicidal and self-harming behavior: a randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Oct;53(10):1082-91. doi: 10.1016/j.jaac.2014.07.003. Epub 2014 Jul 22.
• Results Aboujaoude E, Salame WO. Naltrexone: A Pan-Addiction Treatment? CNS Drugs. 2016 Aug;30(8):719-33. doi: 10.1007/s40263-016-0373-0.
• Results Bresin K, Gordon KH. Endogenous opioids and nonsuicidal self-injury: a mechanism of affect regulation. Neurosci Biobehav Rev. 2013 Mar;37(3):374-83. doi: 10.1016/j.neubiorev.2013.01.020. Epub 2013 Jan 20.
• Results Blasco-Fontecilla H, Fernandez-Fernandez R, Colino L, Fajardo L, Perteguer-Barrio R, de Leon J. The Addictive Model of Self-Harming (Non-suicidal and Suicidal) Behavior. Front Psychiatry. 2016 Feb 1;7:8. doi: 10.3389/fpsyt.2016.00008. eCollection 2016.
• Results Vega D, Sintes A, Fernandez M, Punti J, Soler J, Santamarina P, Soto A, Lara A, Mendez I, Martinez-Gimenez R, Romero S, Pascual JC. Review and update on non-suicidal self-injury: who, how and why? Actas Esp Psiquiatr. 2018 Jul;46(4):146-55. Epub 2018 Jul 1.

Drugs

Indications