Trial · NCT00723749
Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
NCT00723749, Completed, Indivior Inc.; results first posted 2012-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603). Trials, record NCT00723749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00723749
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
- NCT number
- NCT00723749
- Status
- Completed
- Enrollment
- 384 participants, actual
- Lead sponsor
- Indivior Inc.
- Conditions
- Opioid-Related Disorders, Opiate Dependence, Drug Abuse
- Interventions
- Buprenorphine/Naloxone
- First posted
- 2008-07-29
- Last updated
- 2012-04-30
- Results first posted
- 2012-04-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Retention Rate After 12 Months of Treatment With Suboxone | 12 months | The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany. |
| Secondary | Dosage of SUBOXONE® | Day 1 and Final Assessment (month 12 or time of dropout) | Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®. |
| Secondary | Take Home Prescriptions of SUBOXONE® | Day 1 and Final Assessment (month 12 or time of dropout) | Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment. Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis. A patient can receive only one take home prescription for up to 7 days at the time. |
| Secondary | Drug Craving (Subjective Effects of Therapy) | Baseline and Final Assessment (month 12 or time of dropout) | Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Dosage of SUBOXONE® | Day 1 and Final Assessment (month 12 or time of dropout) | The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation). | mg daily dosage of Suboxone | MEAN |
| PRIMARY | Retention Rate After 12 Months of Treatment With Suboxone | 12 months | The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation). | % of participants | NUMBER |
| SECONDARY | Take Home Prescriptions of SUBOXONE® | Day 1 and Final Assessment (month 12 or time of dropout) | The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation). | participants with take home prescription | NUMBER |
| SECONDARY | Drug Craving (Subjective Effects of Therapy) | Baseline and Final Assessment (month 12 or time of dropout) | The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation). | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dosage of SUBOXONE® | Suboxone | Dosage: Day 1 | 9.2 | Standard Deviation 5.1 | mg daily dosage of Suboxone |
| Dosage of SUBOXONE® | Suboxone | Dosage: Final Assessment | 7.7 | Standard Deviation 4.4 | mg daily dosage of Suboxone |
| Retention Rate After 12 Months of Treatment With Suboxone | Suboxone | 59.9 | 95% Confidence Interval 54.9 to 65.1 | % of participants | |
| Take Home Prescriptions of SUBOXONE® | Suboxone | Frequency: Day 1 | 28 | participants with take home prescription | |
| Take Home Prescriptions of SUBOXONE® | Suboxone | Frequency: Final Assessment | 82 | participants with take home prescription | |
| Drug Craving (Subjective Effects of Therapy) | Suboxone | Craving: Baseline | 32.3 | Standard Deviation 33.1 | Units on a scale |
| Drug Craving (Subjective Effects of Therapy) | Suboxone | Craving: Final Assessment | 7.1 | Standard Deviation 17.2 | Units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Suboxone | 345 | |
| Overall Study | COMPLETED | Suboxone | 182 | |
| Overall Study | NOT COMPLETED | Suboxone | 163 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | alcohol withdrawal syndrome | Psychiatric disorders | Suboxone | 1 | 384 | 1 |
| serious | non-compliance | Social circumstances | Suboxone | 1 | 384 | 1 |
| serious | planned abortion | Surgical and medical procedures | Suboxone | 1 | 94 | 1 |
| serious | adjustment disorder | Psychiatric disorders | Suboxone | 1 | 384 | 1 |
| serious | alcohol misuse | Psychiatric disorders | Suboxone | 1 | 384 | 1 |
| serious | acute psychosis | Psychiatric disorders | Suboxone | 1 | 384 | 1 |
| serious | medication addiction | Psychiatric disorders | Suboxone | 1 | 384 | 4 |
| serious | hospitalization | Surgical and medical procedures | Suboxone | 1 | 384 | 1 |
| serious | epilepsy | Nervous system disorders | Suboxone | 1 | 384 | 1 |
| serious | accident at home | Injury, poisoning and procedural complications | Suboxone | 1 | 384 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Suboxone | ||
| Total, other adverse events | Suboxone | 0 | 384 |
| Total, serious adverse events | Suboxone | 10 | 384 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00723749
GET https://conductscience.org/api/trials/v1/NCT00723749/registered