Refractory opioid addicts Mental and Behavioural Disorders Mental and behavioural disorders due to use of opioids
Conditions
Interventions
Participants in the experimental group received DAM (heroin) injection twice a day, plus oral methadone once a day (to be taken at home) for 9 months. The control group received only oral methadone to
for the control group, it was between 361 and 400 mg/day.
Of the 62 participants, 44 completed the treatment and 50 patients were analysed.
Contact details of Principal Investigator:
Dr Joan Carle
Sponsors
Drug Commission, Council for Equality and Social Welfare (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, 21 years or older 2. Long-term opioid-dependent persons who had not been benefited from other treatments Potential participants were interviewed in squares, soup kitchens and methadone dispensaries by outreach workers and peers, who suggested they make an appointment with a PEPSA physician.
Exclusion criteria
Exclusion criteria: 1. Non-agreement to participate 2. Psycho-social impairment to answer the questionnaires 3. Current medical, social or legal situation that is likely to result in an discontinuation period longer than the study period (9 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A dichotomous multidimension outcome (MDO) index was determined by protocol as a primary outcome variable, imputing success when the patient showed at least 20% improvement at 9 months, compared with the baseline values, in general health or psychological or family adjustment, without a deterioration superior to 20% in any of these dimensions evaluated with the respective Addiction Severity Index (ASI) composite scores. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following were assessed before randomisation, at 3, 6 and 9 months (end of the trial): 1. Physical and mental health, assessed by the Opiate Treatment Index (OTI), Symptom Checklist (SCL) and Maudsley Addiction Profile (MAP) 2. Psychosocial adjustment, assessed by the OTI and ASI 3. Treatment retention 4. Illegal activities, assessed by the ASI 5. Illicit drug use, assessed by the OTI and ASI 6. Quality of life, assessed by the Health Related Quality of Life 12-item Short Form (SF-12) | — |
Countries
Spain
Outcome results
None listed