Heroin Assisted Treatment in Andalusia: The PEPSA Trial
| ISRCTN | ISRCTN52023186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52023186 |
| Clinical Trials Information System (CTIS) | 2005-002896-33 |
| Protocol serial number | N/A |
| Sponsor | Drug Commission, Council for Equality and Social Welfare (Spain) |
| Funder | Committee on Drug Dependence, Carlos III Health Institute (Spain) |
- Submission date
- 03/08/2008
- Registration date
- 19/02/2009
- Last edited
- 16/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
School of Population and Public Health
University of British Columbia
Centre for Health Evaluation & Outcome Sciences
St. Paul's Hospital
620-1081 Burrard Street
Vancouver, BC
V6Z 1Y6
Canada
| Phone | +1 604 682 2344 Ext 62973 |
|---|---|
| eugenia@mail.cheos.ubc.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Efficacy of prescribed injected diacetylmorphine in the Andalusian trial: responders and non-responders evaluated using a multi-domain outcome index |
| Study acronym | PEPSA |
| Study objectives | The impact of intravenous diacetylmorphine (DAM) plus oral methadone is better than a treatment with oral methadone alone on the physical and mental health and social integration of refractory opioid addicts. |
| Ethics approval(s) | Ethics board of the Hospital Virgen de las Nieves, approved on 01/08/2001 (ref: 01/15.2) |
| Health condition(s) or problem(s) studied | Refractory opioid addicts |
| Intervention | 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 be taken once a day. Dosage: The two groups received an equivalent opioid dose. Among treatment completers, an average DAM dosage of 274.5 mg/day (range: 15-600 mg) and an average methadone dosage of 42.6 mg/day (range 18-124 mg) were prescribed for the experimental group. The daily methadone dosage in the control group was 105 mg/day (range: 40-180 mg). As a result, the approximate mean daily total equivalent dosage of DAM/day for the experimental group was between 395.5 and 414.5 mg/day; 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 Carles March Andalusian School of Public Health (EASP) Granada 18014, Spain Tel: +34 958 027 400 Email: emilio.pereamilla@gmail.com |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Diacetylmorphine (DAM; heroin), methadone |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
The following were assessed before randomisation, at 3, 6 and 9 months (end of the trial): |
| Completion date | 15/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 62 |
| Key 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. |
| Key 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) |
| Date of first enrolment | 15/02/2003 |
| Date of final enrolment | 15/12/2004 |
Locations
Countries of recruitment
- Canada
- Spain
Study participating centre
V6Z 1Y6
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | main results: | 01/09/2006 | Yes | No | |
| Results article | results | 01/07/2008 | Yes | No | |
| Results article | results, comparing the baseline data from Canadian sample with the European trials, including the data from this trial: | 01/11/2008 | Yes | No | |
| Results article | results | 14/08/2009 | Yes | No | |
| Protocol article | protocol | 01/05/2004 | Yes | No | |
| Other publications | review including data from this trial | 01/07/2007 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
