Mixed neuropathic pain Signs and Symptoms Pain
Conditions
Interventions
Coming out of the cross-over trial mentioned in the inclusion criteria, patients with benefit on either of the study drugs was offered to participate in the open label trial. Nabilone capsules for ora
Sponsors
Cambridge Laboratories Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with chronic neuropathic pain who have previously participated in the trial entitled: 'A randomised, crossover, double blind comparison of the analgesic effect and patient tolerability of nabilone and dihydrocodeine in chronic neuropathic pain' (see ISRCTN15330757) may enter this study. As such, patients will already have satisfied criteria for the diagnosis of chronic neuropathic pain.
Exclusion criteria
Exclusion criteria: Patients may not enter the study if they have a history of any of the following conditions: 1. Epilepsy 2. Liver disease 3. Psychosis 4. Bipolar disorder 5. Substance misuse 6. Renal failure 7. Adverse reactions to nabilone 8. Pregnant women, lactating women or women of childbearing potential not using effective methods of contraception 9. Patients involved in ongoing legal action against a third party in which financial compensation is being sought for personal injury alleged to be the cause of the presenting condition Excluded medication: Patients may not take the following medications during the study: 1. Antipsychotic drugs 2. Benzodiazepine drugs (excepting stable doses of night-time sedatives) 3. Monoamine oxidase inhibitors Patients taking cannabinoid preparations of any kind may not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean monthly pain scores compared to baseline: Visual Analogue Scale (VAS) scores were recorded daily in a diary together with hours slept and sleep interruption. Pain score were averaged over one month and compared to baseline every three months in the analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sleep was measured as hours slept and if the sleep was interrupted or not in the diary 2. Depression and anxiety were measured with the Hospital Anxiety and Depression Score (HAD) at baseline and then every three months 3. Depression 4. Quality of life was measured with the 36-item Short Form questionnaire (SF-36) at baseline and then every three months 5. Side effects were collected monthly with the eight-point questionnaire rating the severity of the side effects on a five point scale plus a field for open comments 6. Psychometric tests performed every three months | — |
Countries
United Kingdom
Outcome results
None listed