Clinical Trials

Low dose Naltrexone in the treatment of dissociative symptoms

[Article in German]

Pape W, Wöller W.

Krankenhaus für Psychosomatische Medizin und Psychotherapie

Nervenarzt. 2014 Nov 26

PMID: 25421416

BACKGROUND: Following the hypothesis that blocking opioid receptors leads to a decline in opiate-modulated dissociative phenomena, experiences with Naltrexoneas medication for dissociative symptoms been gained since 1999 (mainly in doses of 25-100 mg/day).

PATIENTS AND METHODS: In this study patients with severe trauma-related and dissociative disorders were treated with Naltrexone in doses of 2-6 mg/day (0.06 mg/kg body weight).

RESULTS: The low dose treatment with Naltrexone proved to be effective whereby 11 out of 15 patients reported immediate positive effects and seven described a lasting helpful effect. The majority of patients who felt positive effects reported a clearer perception of both their surroundings and their inner life. Assessment of reality and dealing with it improved as did the perception of their own body and affects as well as self-regulation. The treatment was very low in side effects.

CONCLUSION: Treatment with low-dose Naltrexone may be a helpful element in the treatment of patients with complex post-traumatic stress disorder. However, it has to be realized that the decrease of dissociation may lead patients to a not yet resolvable challenge, in as much as dissociation had previously been a necessary mechanism of self-protection.

Safety and tolerability of Low-Dose Naltrexone therapy in children with moderate to severe Crohn's disease: a pilot study

Smith JP, Field D, Bingaman SI, Evans R, Mauger DT.

Pennsylvania State University

J Clin Gastroenterol. 2013 Apr;47(4):339-45.

PMID: 23188075

BACKGROUND: There is an unmet need for safe and effective medicines to treat children with Crohn's disease. Recently, investigations have shown an association between endogenous opioid peptides and inflammatory cells.

AIMS: The aims of this study were to evaluate the safety and tolerability of an opioid antagonist,Naltrexone, in children with moderate to severe Crohn's disease.

METHODS: A pilot clinical trial was conducted in children with moderate to severe Crohn's disease. Fourteen subjects with a mean age of 12.3 years (range, 8 to 17 y) were enrolled. Children were randomized to placebo or Naltrexone (0.1 mg/kg) orally for 8 weeks followed by open-labeled treatment with 8 additional weeks of Naltrexone. Safety and toxicity were monitored by physical examinations and blood chemistries. Clinical activity was assessed by the Pediatric Crohn's Disease Activity Index (PCDAI) and Quality of life was monitored by the Impact III survey.

RESULTS: Oral Naltrexone was well tolerated without any serious adverse events in children with moderate to severe Crohn's disease. PCDAI scores significantly decreased from pretreatment values (34.2±3.3) with an 8-week course of Naltrexone therapy (21.7±3.9) (P=0.005). Twenty-five percent of those treated with Naltrexone were considered in remission (score ≤10) and 67% had improved with mild disease activity (decrease in PCDAI score by at least 10 points) at the end of the study. Systemic and social quality of life improved with Naltrexone treatment (P=0.035).

CONCLUSIONS: Naltrexone therapy seems safe with limited toxicity when given to children with Crohn's disease and may reduce disease activity.