Trial · NCT00604188
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
NCT00604188, Phase 4, Completed, Merck Sharp & Dohme LLC; results first posted 2011-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED). Trials, record NCT00604188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00604188
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
- NCT number
- NCT00604188
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 188 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Opiate Dependence, Drug Dependence, Substance Dependence
- Interventions
- Suboxone (SCH 000484), Subutex (SCH 028444)
- First posted
- 2008-01-30
- Last updated
- 2017-07-02
- Results first posted
- 2011-05-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responders at Day 3 | 3 days | Responders included the number of participants who received the scheduled dose of Suboxone at the Day 3 study visit. Participants who discontinued the study at Day 3 were considered non-responders. All participants that continued the study received Suboxone tablets on Day 3. |
| Secondary | Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS) | 28 days | Number of participants who tested negative on UDS during open-label phase on Day 28. The drugs screened on Day 28 included amphetamines, methamphetamines, cocaine, morphine, methadone, benzodiazepines, and tetrahydrocannabinol. Buprenorphine was only tested at screening and randomization according to protocol, therefore no values for buprenorphine are available for Day 28. |
| Secondary | Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI) | Days 3 to 28 | Number of participants with intravenous use of drug as measured by self-reported SUI from Days 3-28. The SUI form consisted of questions addressing the number of days and times a drug was used, and the route of drug use. For suboxone the use of scheduled study medication was not considered illicit use. |
| Secondary | Self-reported Opioid Withdrawal Symptoms (SOWS) | Baseline and 28 days | SOWS were 16 items whose intensity was scored on a scale from 0 (not at all) to 4 (extremely) for a maximum possible score of 64. A total score of 0 represented the best outcome and a score of 64 represented the worst outcome. Participants were scored for SOWS at baseline (prior to randomization) and on Day 28. Reported are the scores for Day 28, and the change in scores from baseline to Day 28. |
| Secondary | Observer-rated Opioid Withdrawal Symptoms (OOWS) | Baseline and 28 days | The OOWS were 13 physically observable signs that were present (scored 1) or absent (scored 0). A total score of 0 represented the best outcome and a total score of 13 represented the worst outcome. Participants were scored for OOWS at baseline (prior to randomization) and on Day 28. Reported are the total score for Day 28, and the change in scores from baseline to Day 28. |
| Secondary | Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric | Baseline and 28 days | The ASI-Lite is a standardized, multidimensional, semi-structured, comprehensive interview that estimates addiction-related problem severity profiles in seven domains commonly affected in substance abusers. ASI-lite composite score ranges from 0 (worst outcome) to 1 (best outcome) for each category. Reported here is the change in ASI-Lite from baseline to Day 28. The original drug use accounts for heroin, methadone, other opiates, analgesics, medicine/pills, cocaine, amphetamines, cannabis, hallucinogens, and inhalants. Modified drug use accounts for heroin, methadone, cocaine, and cannabis. |
| Secondary | Compliance Rate | 28 days | Compliance rate was calculated as the number of days study medication was taken divided by the number of days study medication should have been taken X 100. The number of days study medication should have been taken was equal to the duration of treatment. |
| Secondary | Responders at Day 28 | 28 days | Responders were the number of participants in each group who received the scheduled 8- to 24-mg dose of Suboxone at study visit day. A participant who discontinued from the study was treated as a non-responder at the timepoint after the participant discontinued. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Responders at Day 3 | 3 days | ITT population | Participants | NUMBER |
| SECONDARY | Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS) | 28 days | Participants with missing data were not included in the analysis. | Participants | NUMBER |
| SECONDARY | Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI) | Days 3 to 28 | ITT population | Participants | NUMBER |
| SECONDARY | Self-reported Opioid Withdrawal Symptoms (SOWS) | Baseline and 28 days | Participants with SOWS data reviewed for completeness and within visit date consistency were analyzed. | Score on a scale | MEAN |
| SECONDARY | Observer-rated Opioid Withdrawal Symptoms (OOWS) | Baseline and 28 days | Participants with OOWS data reviewed for completeness and within visit date consistency were analyzed. | Score on a scale | MEAN |
| SECONDARY | Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric | Baseline and 28 days | ITT population. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Compliance Rate | 28 days | ITT population | Percentage of days | MEAN |
| SECONDARY | Responders at Day 28 | 28 days | ITT population | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Responders at Day 3 | Direct Suboxone Induction | Responders | 85 | Participants | |
| Responders at Day 3 | Subutex-to-Suboxone Induction | Responders | 85 | Participants | |
| Responders at Day 3 | Direct Suboxone Induction | Non responders | 8 | Participants | |
| Responders at Day 3 | Subutex-to-Suboxone Induction | Non responders | 9 | Participants | |
| Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS) | Direct Suboxone Induction | Tetrahydrocannabinol | 65 | Participants | |
| Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS) | Subutex-to-Suboxone Induction | Tetrahydrocannabinol | 59 | Participants | |
| Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS) | Direct Suboxone Induction | Cocaine | 70 | Participants | |
| Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS) | Subutex-to-Suboxone Induction | Cocaine | 69 | Participants | |
| Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS) | Direct Suboxone Induction | Amphetamines | 77 | Participants | |
| Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS) | Subutex-to-Suboxone Induction | Amphetamines | 81 | Participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Direct Suboxone Induction | 93 | |
| Overall Study | STARTED | Subutex-to-Suboxone Induction | 95 | |
| Overall Study | COMPLETED | Direct Suboxone Induction | 66 | |
| Overall Study | COMPLETED | Subutex-to-Suboxone Induction | 70 | |
| Overall Study | NOT COMPLETED | Direct Suboxone Induction | 27 | |
| Overall Study | NOT COMPLETED | Subutex-to-Suboxone Induction | 25 |
Source ClinicalTrials.gov
Adverse events48
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 |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Direct Suboxone Induction | 5 | 93 | 5 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Subutex-to-Suboxone Induction | 4 | 94 | 5 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Direct Suboxone Induction | 1 | 93 | 1 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Subutex-to-Suboxone Induction | 6 | 94 | 7 |
| other | NAUSEA | Gastrointestinal disorders | Direct Suboxone Induction | 8 | 93 | 9 |
| other | NAUSEA | Gastrointestinal disorders | Subutex-to-Suboxone Induction | 14 | 94 | 15 |
| other | TOOTHACHE | Gastrointestinal disorders | Direct Suboxone Induction | 6 | 93 | 6 |
| other | TOOTHACHE | Gastrointestinal disorders | Subutex-to-Suboxone Induction | 1 | 94 | 1 |
| other | VOMITING | Gastrointestinal disorders | Direct Suboxone Induction | 15 | 93 | 16 |
| other | VOMITING | Gastrointestinal disorders | Subutex-to-Suboxone Induction | 11 | 94 | 12 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Direct Suboxone Induction | ||
| Total, all-cause mortality | Subutex-to-Suboxone Induction | ||
| Total, other adverse events | Direct Suboxone Induction | 61 | 93 |
| Total, other adverse events | Subutex-to-Suboxone Induction | 64 | 94 |
| Total, serious adverse events | Direct Suboxone Induction | 1 | 93 |
| Total, serious adverse events | Subutex-to-Suboxone Induction | 3 | 94 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21749526 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Direct Suboxone Induction vs Subutex-to-Suboxone Induction: serious adverse events |
Source Trial comparisons
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/NCT00604188
GET https://conductscience.org/api/trials/v1/NCT00604188/results?page=2