Completion of OST - a Prospective Study

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Completed
• CT.gov ID: NCT01722435
• Collaborator: Asklepios Kliniken Hamburg GmbH (Other), Dr. Rainer Ullmann (Other), Dr. Sibylle Quellhorst (Other), Dr. Jochen Brack (Other), Michael Klemperer (Other), Gesine Hoeft (Other)
• Enrollment: 78
• Duration (Months): 31.1

Study Details

Study Description

Brief Summary

Only limited information on the process of completing long-term opiate substitution treatment (OST) with substances like methadone exist. Furthermore, systematic knowledge from scientific studies is scarce, there are only few studies with respect to treatment completion or regular termination (mainly catamnestic analyses). Studies by Nordt et al. (2004) or Nordt & Stohler (2006) show an estimated rate of 10% of patients per year who terminate OST by means of tapering the substitution agent or changing into withdrawal treatment in specialized clinics. It is state of the art that an indication for termination of OST has to be based on a common agreement between the patient and the doctor. Furthermore, the patient should live in a stable social situation and the state of health had markedly improved. Finally, the patient has to be free of (illegal) drug use for at least 6 months and the individual aims of treatment should have been reached (Vader et al. 2003).

The main objective of the prospective and explorative study is the systematic description of the process of termination of OST. With a comparison between patients who complete OST regularly and patients who terminate treatment prematurely (or are still in treatment) predictors of positive termination of OST can be identified.

Patients treated with methadone or levomethadone of 5 general practitioners' practices and 2 specialized clinics who might be able to terminate OST during the next 12 months from the doctors' perspective can take part in the study. In addition to baseline examination further assessments take place every 3 months (i.e. after 3, 6, 9 and 12 months). The questionnaires include state of health, well-being, social situation as well as drug and alcohol use. Furthermore, the treating doctors are asked every 3 months to fill out questionnaires on infections and other disorders, clinical characteristics, dosage process and drug use (measured by urine samples).

Patients who will be successful in completing OST during the observational period will be compared with the remaining cases.

Finally, a 6-month follow-up is planned in order to investigate the stability and maintenance of the situation at month 12.

Condition or Disease	Intervention/Treatment	Phase
Opioid Dependence	Drug: Opiate Substitution Treatment

Study Design

• Study Type: Observational
• Actual Enrollment: 78 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Completion of Substitution Treatment With Methadone/Levomethadone - a Prospective Study
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
OST completers Patients who are likely to complete OST during the next 12 or 18 months	Drug: Opiate Substitution Treatment

Outcome Measures

Primary Outcome Measures

1. Completion of OST [18 months]

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

2. OST Drop-outs [18 months]

   Participants dropped out of OST Treatment during the study period.

Secondary Outcome Measures

1. Mean Time to Complete OST [18 months]

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

2. Mean Time to Drop-out of OST [18 months]

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

3. Mean Time Staying in OST [18 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• opioid dependence according ICD-10

• Minimum age of 18 years

• In OST with methadone or levomethadone

• Expected or planned treatment completion during the next 12 months

• Informed consent to participate in the study

Exclusion Criteria:

• Patients with planned hospitalisation during the next 12 months

• Patients who are likely or it is save to assume that they will be incarcerated or imprisoned during the next 12 months

• Disability to take part in the study or follow the study conditions

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universitätsklinikum Hamburg-Eppendorf
• Asklepios Kliniken Hamburg GmbH
• Dr. Rainer Ullmann
• Dr. Sibylle Quellhorst
• Dr. Jochen Brack
• Michael Klemperer
• Gesine Hoeft

Investigators

• Principal Investigator: Jens Reimer, Professor, Centre for Interdisciplinary Addiction Research of Hamburg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Dr. med. Jens Reimer, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT01722435
• Other Study ID Numbers: ZIS-OST-PV3718
• First Posted: Nov 6, 2012
• Last Update Posted: Oct 9, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by Prof. Dr. med. Jens Reimer, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf: opioid dependence; opiate substitution treatment; methadone; completion; termination
• Additional relevant MeSH terms: Opioid-Related Disorders; Opiate Alkaloids

Study Results

Participant Flow

Arm/Group Title	OST Completers
Arm/Group Description	Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
Period Title: Overall Study
STARTED	78
COMPLETED	78
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	OST Completers
Arm/Group Description	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).
Overall Participants	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.5 (7.9)
Sex: Female, Male (Count of Participants)
Female	54 69.2%
Male	24 30.8%
Lengths of OST before study entry (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	92.9 (59.5)
Participants on specific medication (participants) [Number]
d,l-methadone	37 47.4%
levometahdone	37 47.4%
buprenorphine	4 5.1%
Average dose of medication taken (milligrams) [Mean (Standard Deviation) ]
d,l-methadone	54.8 (41.8)
levomethadone	26.6 (21.6)
buprenorphine	14.3 (8.2)

Outcome Measures

1. Primary Outcome

Title	Completion of OST
Description	Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OST Completers
Arm/Group Description	Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
Measure Participants	78
Number [participants]	9 11.5%

2. Primary Outcome

Title	OST Drop-outs
Description	Participants dropped out of OST Treatment during the study period.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OST Completers
Arm/Group Description	Patients who are likely to complete OST during the next 12 or 18 months.
Measure Participants	78
Number [participants]	15 19.2%

3. Secondary Outcome

Title	Mean Time to Complete OST
Description	Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OST Completers
Arm/Group Description	Patients completed OST during 12 or 18 months.
Measure Participants	9
Mean (Standard Deviation) [days]	232 (159)

4. Secondary Outcome

Title	Mean Time to Drop-out of OST
Description	Mean time of study participation (M, SD) until drop-out of treatment.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OST Drop-outs
Arm/Group Description	Patients dropped out of OST during 12 or 18 months.
Measure Participants	15
Mean (Standard Deviation) [days]	315 (195)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Still in OST Completers
Arm/Group Description	Patients still in OST during the whole study period.
Measure Participants	54
Mean (Standard Deviation) [days]	549 (91)

Adverse Events

Arm/Group Title	OST Completers
Arm/Group Description	Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
All Cause Mortality
	OST Completers
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	OST Completers
	Affected / at Risk (%)	# Events
Total	0/78 (0%)
Other (Not Including Serious) Adverse Events
	OST Completers
	Affected / at Risk (%)	# Events
Total	0/78 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.