Trial Outcomes & Findings for Completion of OST - a Prospective Study (NCT NCT01722435)

Results Overview

Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.

Recruitment status

COMPLETED

Target enrollment

78 participants

Primary outcome timeframe

18 months

Results posted on

2019-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	OST Completers Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
Overall Study STARTED	78
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Completion of OST - a Prospective Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OST Completers n=78 Participants The main objective of this prospective study was the description of the process of termination of opiate substitution treatment (OST). Patients in primary care setting (GPs) or specialized clinics likely to complete OST during the next 12 months were asked to fill out questionnaires every 3 months over a 12-months period and were followed up another 6 months later. Accordingly, the doctors documented their patients' state of health and provided an evaluation of their living situation every 3 months and at the end of treatment (or - if patients stayed in treatment - at the end of the 18-months study period). At the beginning of the study overall 1367 OST patients were treated in the 7 participating clinics and practices. 972 of them were treated with methadone or levomethadone. In line with the inclusion criteria, 97 patients were eligible for the study, 78 of them consented to participate in the study (8.0% of all patients treated with methadone or levomethadone).
Age, Continuous	39.5 years STANDARD_DEVIATION 7.9 • n=99 Participants
Sex: Female, Male Female	54 Participants n=99 Participants
Sex: Female, Male Male	24 Participants n=99 Participants
Lengths of OST before study entry	92.9 months STANDARD_DEVIATION 59.5 • n=99 Participants
Participants on specific medication d,l-methadone	37 participants n=99 Participants
Participants on specific medication levometahdone	37 participants n=99 Participants
Participants on specific medication buprenorphine	4 participants n=99 Participants
Average dose of medication taken d,l-methadone	54.8 milligrams STANDARD_DEVIATION 41.8 • n=99 Participants
Average dose of medication taken levomethadone	26.6 milligrams STANDARD_DEVIATION 21.6 • n=99 Participants
Average dose of medication taken buprenorphine	14.3 milligrams STANDARD_DEVIATION 8.2 • n=99 Participants

PRIMARY outcome

Timeframe: 18 months

Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.

Outcome measures

Outcome measures
Measure	OST Completers n=78 Participants Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
Completion of OST	9 participants

PRIMARY outcome

Timeframe: 18 months

Participants dropped out of OST Treatment during the study period.

Outcome measures

Outcome measures
Measure	OST Completers n=78 Participants Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
OST Drop-outs	15 participants

SECONDARY outcome

Timeframe: 18 months

Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).

Outcome measures

Outcome measures
Measure	OST Completers n=9 Participants Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
Mean Time to Complete OST	232 days Standard Deviation 159

SECONDARY outcome

Timeframe: 18 months

Mean time of study participation (M, SD) until drop-out of treatment.

Outcome measures

Outcome measures
Measure	OST Completers n=15 Participants Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
Mean Time to Drop-out of OST	315 days Standard Deviation 195

SECONDARY outcome

Timeframe: 18 months

Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months).

Outcome measures

Outcome measures
Measure	OST Completers n=54 Participants Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
Mean Time Staying in OST	549 days Standard Deviation 91

Adverse Events

OST Completers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Jens reimer

Centre for Interdisciplinary Addiction research of Hamburg University ZIS

Phone: +4940741057900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place