Trial · NCT00115037
Managing Alcoholism in People Who Do Not Respond to Naltrexone
NCT00115037, Phase 4, Completed, University of Pennsylvania; results first posted 2019-09-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Managing Alcoholism in People Who Do Not Respond to Naltrexone. Trials, record NCT00115037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00115037
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Managing Alcoholism in People Who Do Not Respond to Naltrexone
- NCT number
- NCT00115037
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 302 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Alcoholism
- Interventions
- Naltrexone, placebo, Medication Management (MM), Combined Behavioral Intervention (CBI), Telephone Counseling
- First posted
- 2005-06-21
- Last updated
- 2019-09-18
- Results first posted
- 2019-09-18
- Limitations and caveats
- Overall the sample size was limited for detecting results in the second phase.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Count of Responders and Non-responders in Phase 1 | 8 weeks | This is the number of patients who responded to phase 1 treatment based on the definition that subjects were randomly assigned to. |
| Primary | Percentage of Heavy Drinking Days | 16 weeks | Percentage of days with heavy drinking, where heavy drinking is 4 (5) or more drinks for females (males) in a 24 hour period. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Count of Responders and Non-responders in Phase 1 | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Percentage of Heavy Drinking Days | 16 weeks | percentage days of heavy drinking | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Count of Responders and Non-responders in Phase 1 | Phase 1 Liberal Response | 103 | Participants | ||
| Count of Responders and Non-responders in Phase 1 | Phase 1 Stringent Response | 80 | Participants | ||
| Percentage of Heavy Drinking Days | Phase 2 Naltrexone for Responders | 0 | Inter-Quartile Range 0 to 4.8 | percentage days of heavy drinking | |
| Percentage of Heavy Drinking Days | Phase 2 Nalt and Tele for Responders | 0 | Inter-Quartile Range 0 to 3.2 | percentage days of heavy drinking | |
| Percentage of Heavy Drinking Days | Phase 2 Nalt, MM and CBI for NR | 27.7 | Inter-Quartile Range 2.8 to 61.6 | percentage days of heavy drinking | |
| Percentage of Heavy Drinking Days | Phase 2 Placebo, MM and CBI for NR | 17.8 | Inter-Quartile Range 0 to 58.7 | percentage days of heavy drinking |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase1 | STARTED | Phase1: Liberal | 152 | |
| Phase1 | STARTED | Phase1: Stringent | 150 | |
| Phase1 | STARTED | Phase2: Responder - Naltx (Usual Care) | 0 | |
| Phase1 | STARTED | Phase2: Responder - Naltx+Phone (TDM) | 0 | |
| Phase1 | STARTED | Phase2: Non-responder - Naltx, MM and CBI | 0 | |
| Phase1 | STARTED | Phase2: Non-responder - Placebo, MM and CBI | 0 | |
| Phase1 | COMPLETED | Phase1: Liberal | 127 | |
| Phase1 | COMPLETED | Phase1: Stringent | 123 | |
| Phase1 | COMPLETED | Phase2: Responder - Naltx (Usual Care) | 0 | |
| Phase1 | COMPLETED | Phase2: Responder - Naltx+Phone (TDM) | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase1: Liberal | 0 | 152 |
| Total, all-cause mortality | Phase1: Stringent | 0 | 150 |
| Total, all-cause mortality | Phase2: Responder - Naltx (Usual Care) | 1 | 91 |
| Total, all-cause mortality | Phase2: Responder - Naltx+Phone (TDM) | 0 | 92 |
| Total, all-cause mortality | Phase2: Non-responder - Naltx, MM and CBI | 0 | 34 |
| Total, all-cause mortality | Phase2: Non-responder - Placebo, MM and CBI | 1 | 33 |
| Total, other adverse events | Phase1: Liberal | 0 | 152 |
| Total, other adverse events | Phase1: Stringent | 0 | 150 |
| Total, other adverse events | Phase2: Responder - Naltx (Usual Care) | 0 | 91 |
| Total, other adverse events | Phase2: Responder - Naltx+Phone (TDM) | 0 | 92 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20716308 | 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 |
|---|
| Phase 1 Liberal Response vs Phase 1 Stringent Response: Count of Responders and Non-responders in Phase 1 |
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/NCT00115037
GET https://conductscience.org/api/trials/v1/NCT00115037/flow?page=2