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On the basis of the inclusion and exclusion criteria described
above, the potential candidates for participation in the trials were recruited
in a selection procedure which, in broad terms, involved the following steps:
1. pre-selection of a source population on the basis of the available information
from the methadone treatment registration system;
2. patients in the source population were invited in a random order to an initial
meeting with the physician of the local treatment unit; subsequent screening
on various selection criteria and provision of oral and written information;
3. candidates who met the initial selection criteria and who provided initial
informed consent entered the qualification period; an initial screening
took place in which all selection criteria were examined;
4. four to eight weeks later a final screening was conducted among the candidates
who had passed the initial screening; during this final screening, the
most important selection criteria were again assessed, and final informed consent
was obtained;
5. randomization took place with all patients who met all inclusion criteria
and were not barred by any of the exclusion criteria at the final screening.
Step 1. Registration system
In the first selection step, the available information from
the methadone maintenance treatment registration system was examined, with regard
to the following selection criteria:
Step 2. Initial meeting
All patients who met the criteria described above received
a randomly assigned patient identifier number, and were invited to an initial
meeting with the physician of the local treatment site in the order of their
identifier number. During this meeting, the patient received extensive oral
and written information about the objectives and procedures in the study, the
potential benefits and risks for the patient, and the expected co-operation
during the study. In addition, the following selection criteria were examined:
Step 3. Initial screening
Patients who met the criteria described in step 2 and who
were not barred by exclusion criteria were referred to the local research team
and the physician for an initial screening assessment in the four to eight weeks
qualification period of the study. Prior to the screening assessment, the physician
obtained initial written informed consent from the patient. During this initial
screening, the following selection criteria were examined:
Step 4. Final screening (baseline assessment)
Four to eight weeks after the initial screening, patients
who met the criteria described in step 3 and who were not barred by exclusion
criteria received their final screening assessment. Prior to the final screening,
patients were asked to provide final written informed consent. The following
selection criteria were examined:
Step 5. Randomization
Within three to four days after the final screening (baseline
assessment), all patients who had provided informed consent, met all inclusion
criteria, and who were not barred by any of the exclusion criteria were randomized
to one of the treatment conditions. Within days following the outcome of the
randomization procedure, all patients were orally informed by the local treatment
staff about the treatment condition they were randomized to.