Condition category
Injury, Occupational Diseases, Poisoning
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr A. Wieringa


Contact details

Martini Hospital
Department of Pharmacy
P.O. Box 30033
9700 RM
+31 (0)50 524 5771

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Treatment of itch with naltrexone in patients with burns: an explorative, randomised, double blind, placebo-controlled, cross-over clinical trial


BITE (Burns Itch TreatmEnt study)

Study hypothesis

The primary objective of this study is to evaluate the efficacy and safety of naltrexone in the treatment of itch in patients with burn wounds.

Ethics approval

Ethics approval received from the local ethics board (Stichting Beoordeling Ethiek Biomedisch Onderzoek, Medisch Ethische toetsingscommissie [METC Assen]) on the 4th July 2007 (ref: MZH 2007-20).

Study design

Randomised, double-blind, placebo controlled, crossover group trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet




Patients will take either naltrexone or placebo for two weeks and are randomised to start with one or the other. Before the two treatment periods a baseline measurement of 7 days will be done. In between the two treatment periods there will be a wash-out period of 3 days. The naltrexone dose will be 50 mg once daily. On the first day patients will receive two times 25 mg of naltrexone with at least one hour in between. The procedure on the first day will be mimicked where the placebo is concerned.

Intervention type



Not Specified

Drug names

Primary outcome measure

1. Mean itch intensity score at endpoint, defined as the mean of the last 7 diary entries while the patient is receiving study medication. The percentage change in itch intensity score from baseline is calculated as:
1 - (mean itch intensity score end point/mean itch intensity score baseline) x 100%

Secondary outcome measures

1. Additional aspects of itch (e.g. frequency, duration)
2. The effect of treatment as perceived by the patient, pain, and various aspects of anxiety and sleep:
2.1. Itch presence, measured at baseline 1
2.2. Demographics, measured at baseline 1
2.3. Burn injury characteristics, measured at baseline 1
2.4. Polymorphism µ-receptor (DNA), measured at intervention week 2
2.5. Blood plasma level, measured at intervention week 2 and intervention week 4
2.6. Scar:
2.6.1. Patient and Observer Scar Assessment Scale (POSAS), measured at baseline 1 and intervention week 4
2.6.2. Dermaspect, measured at baseline 1 and intervention week 4
2.7. Itch:
2.7.1. Visual Analogue Scale (VAS) measured daily throughout treatment
2.7.2. Body-Image Ideals Questionnaire (BIQ), measured at baseline 1, intervention week 1, intervention week 2, baseline 2, intervention week 3, intervention week 4
2.8. Sleep:
2.8.1. Visual Analogue Scale (VAS) measured daily throughout treatment
2.8.2. Medical Outcomes Study (MOS)-Sleep, measured at baseline 1, intervention week 1, baseline 2, intervention week 3
2.9. Pain: Visual Analogue Scale (VAS) measured daily throughout treatment
2.10. Anxiety: Hamilton Anxiety and Depression Scale (HADS), measured at baseline 1, intervention week 1, baseline 2, intervention week 3
2.11. Treatment effect: Patient Global Impression of Change (PGIC), measured at intervention 2 and intervention 4
2.12. Adverse Drug Reaction, measured daily during the intervention and wash out periods

Baseline 1: 7 days
Intervention week 1: 7 days
Intervention week 2: 7 days
Wash-out 1: three days
Baseline 2: 7 days
Intervention week 3: 7 days
Intervention week 4: 7 days
Wash-out 2: 3 days

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Eligible for inclusion are patients:
1. With (almost) healed burns who have been admitted to the burn centre
2. Who are 18 years of age or older with itch 4 - 6 weeks post burn

Participant type


Age group



Not Specified

Target number of participants


Participant exclusion criteria

Patients will be excluded when meeting one of the following exclusion criteria:
1. Total Body Surface Area (TBSA) of more than 20%
2. Liver insufficiency (in this study that means more than two times the normal range of the liver enzymes: Aspartate Aminotransferase [ASAT] greater than 80 U/L and/or Alanine Aminotransferase [ALAT] greater than 80 U/L and/or Alkaline Phosphatase [AP] greater than 250U/L and/or Gamma Glutamyl Transpeptidase [GGT] greater than 100U/L)
3. Acute hepatitis
4. History of drug/alcohol abuse
5. Known sensitivity for any of the following substances: naltrexonehydrochloride, lactose monohydrate, crospovidone, powder cellulose, microcrystalline cellulose, colloid silicon dioxide, magnesium stearate, hypromellose, macrogole 4000, Titanium dioxide (E171), Black iron oxide (E172), Red iron oxide (E172), Yellow iron oxide (E172), carboxymethylamylum sodium type A, precirole
6. Pregnant
7. Breast feeding
8. Having used opioids 10 days prior to the start of treatment
9. Using itch medication other than the study medication and unwilling to stop
10. Psychiatric disorder
11. Other disease associated with itch (e.g. eczema, atopic dermatitis, cholestatic pruritus)
12. Insufficiently proficient in Dutch to give informed consent and/or fill out the questionnaires

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Martini Hospital
9700 RM

Sponsor information


Martini Hospital (The Netherlands)

Sponsor details

Department of Surgery
P.O. Box 30033
9700 RM

Sponsor type

Hospital/treatment centre



Funder type

Research organisation

Funder name

Association of Dutch Burn Centres (ADBC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes