Trial · NCT02611752
A Multiple Dose Opioid Challenge Study
NCT02611752, Phase 2, Completed, Braeburn Pharmaceuticals; results first posted 2019-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multiple Dose Opioid Challenge Study. Trials, record NCT02611752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02611752
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multiple Dose Opioid Challenge Study
- NCT number
- NCT02611752
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Braeburn Pharmaceuticals
- Conditions
- Moderate or Severe Opioid Use Disorder
- Interventions
- CAM2038
- First posted
- 2015-11-23
- Last updated
- 2019-11-14
- Results first posted
- 2019-11-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | 17 days | Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome. |
| Primary | Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg | 17 days | Treatment Phase Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Baseline and Four Challenge sessions Compared to Baseline (Completer Population), where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome. |
| Primary | Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg | 17 days | Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome. |
| Primary | Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg | 17 days | Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item "At this moment, my liking of this drug is" for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 32 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome. |
| Secondary | Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) | 15 days | Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I feel high" where values can range from 0 (Not at all High) to 100 (Extremely High). |
| Secondary | Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) | 15 days | Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseling and four challenge sequences with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I feel good drug effects" where values can range from 0 (Not at all ) to 100 (Extremely). |
| Secondary | Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population) | 15 days | Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, I feel bad effects" where values can range from 0 (Not at all) to 100 (Extremely). |
| Secondary | Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population) | 15 days | Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, I feel bad effects" where values can range from 0 (Not at all) to 100 (Extremely). |
| Secondary | Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) | 15 days | Analysis Results for Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item "At this moment, I desire opiods" where values can range from 0 (Definitely not) to 100 (Definitely so). |
| Secondary | Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) | 15 days | Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item "At this moment, my mental state is" where values can range from 0 (Very Drowsy) to 100 (Very alert), with 50 being neutral (Neither drowsy nor alert). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | 17 days | Mean Drug Liking VAS Scores over Time for CAM2038 q1w 24 mg by Hydromorphone Challenge Session, Completer Population (N=22) | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg | 17 days | Mean Drug Liking VAS Scores over Time for CAM2038 q1w 32 mg by Hydromorphone Challenge Session, Completer Population (N=24) | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg | 17 days | Mean Drug Liking VAS Scores over Time for CAM2038 q1w 24 mg by Hydromorphone Challenge Session, Completer Population (N=22) | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg | 17 days | Mean Drug Liking VAS Scores over Time for CAM2038 q1w 32 mg by Hydromorphone Challenge Session, Completer Population (N=24) | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) | 15 days | Completer Population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) | 15 days | Completer Population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population) | 15 days | Completer Population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population) | 15 days | Completer Population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) | 15 days | (Completer Population) | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) | 15 days | (Completer Population) | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group240
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | CAM2038 q1w, 24 mg - Hydromorphone 0 mg | Baseline | 50.6 | Standard Error 1.48 | units on a scale |
| Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | CAM2038 q1w, 24 mg - Hydromorphone 6 mg | Baseline | 83.2 | Standard Error 1.48 | units on a scale |
| Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | CAM2038 q1w, 24 mg - Hydromorphone 18 mg | Baseline | 92.7 | Standard Error 1.48 | units on a scale |
| Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | CAM2038 q1w, 24 mg - Hydromorphone 0 mg | Days 1-3 | 51.3 | Standard Error 0.84 | units on a scale |
| Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | CAM2038 q1w, 24 mg - Hydromorphone 6 mg | Days 1-3 | 52.2 | Standard Error 0.84 | units on a scale |
| Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | CAM2038 q1w, 24 mg - Hydromorphone 18 mg | Days 1-3 | 53.1 | Standard Error 0.84 | units on a scale |
| Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | CAM2038 q1w, 24 mg - Hydromorphone 0 mg | Days 4-6 | 50.8 | Standard Error 0.84 | units on a scale |
| Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | CAM2038 q1w, 24 mg - Hydromorphone 6 mg | Days 4-6 | 52.1 | Standard Error 0.84 | units on a scale |
| Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | CAM2038 q1w, 24 mg - Hydromorphone 18 mg | Days 4-6 | 58.3 | Standard Error 0.84 | units on a scale |
| Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg | CAM2038 q1w, 24 mg - Hydromorphone 0 mg | Days 8 -10 | 51.1 | Standard Error 0.84 | units on a scale |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CAM2038 q1w, 24 mg | 22 | |
| Overall Study | STARTED | CAM2038 q1w, 32 mg | 25 | |
| Overall Study | Day 1-3 Hydromorphone Challenge Injs | CAM2038 q1w, 24 mg | 22 | |
| Overall Study | Day 1-3 Hydromorphone Challenge Injs | CAM2038 q1w, 32 mg | 25 | |
| Overall Study | Day 4-6 Hydromorphone Challenge Injs | CAM2038 q1w, 24 mg | 22 | |
| Overall Study | Day 4-6 Hydromorphone Challenge Injs | CAM2038 q1w, 32 mg | 24 | |
| Overall Study | Day 8-10 Hydromorphone Challenge Injs | CAM2038 q1w, 24 mg | 22 | |
| Overall Study | Day 8-10 Hydromorphone Challenge Injs | CAM2038 q1w, 32 mg | 24 | |
| Overall Study | Day11-13 Hydromorphone Challenge Injs | CAM2038 q1w, 24 mg | 22 | |
| Overall Study | Day11-13 Hydromorphone Challenge Injs | CAM2038 q1w, 32 mg | 24 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events22
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 | Constipation | Gastrointestinal disorders | CAM2038 q1w, 24 mg | 3 | 22 | |
| other | Constipation | Gastrointestinal disorders | CAM2038 q1w, 32 mg | 6 | 25 | |
| other | Nausea | Gastrointestinal disorders | CAM2038 q1w, 24 mg | 1 | 22 | |
| other | Nausea | Gastrointestinal disorders | CAM2038 q1w, 32 mg | 3 | 25 | |
| other | Faeces Hard | Gastrointestinal disorders | CAM2038 q1w, 24 mg | 0 | 22 | |
| other | Faeces Hard | Gastrointestinal disorders | CAM2038 q1w, 32 mg | 2 | 25 | |
| other | Injection Site Pain | General disorders | CAM2038 q1w, 24 mg | 2 | 22 | |
| other | Injection Site Pain | General disorders | CAM2038 q1w, 32 mg | 3 | 25 | |
| other | Injection Site Erythema | General disorders | CAM2038 q1w, 24 mg | 2 | 22 | |
| other | Injection Site Erythema | General disorders | CAM2038 q1w, 32 mg | 2 | 25 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CAM2038 q1w, 24 mg | 0 | 22 |
| Total, all-cause mortality | CAM2038 q1w, 32 mg | 0 | 25 |
| Total, other adverse events | CAM2038 q1w, 24 mg | 13 | 22 |
| Total, other adverse events | CAM2038 q1w, 32 mg | 24 | 25 |
| Total, serious adverse events | CAM2038 q1w, 24 mg | 0 | 22 |
| Total, serious adverse events | CAM2038 q1w, 32 mg | 0 | 25 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CAM2038 q1w, 24 mg vs CAM2038 q1w, 32 mg: deaths from any cause | Trial comparisons |
| CAM2038 q1w, 24 mg vs CAM2038 q1w, 32 mg: serious adverse events | 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/NCT02611752
GET https://conductscience.org/api/trials/v1/NCT02611752/results?page=2