Trial · NCT00920829
Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism
NCT00920829, Phase 4, Completed, Medical University of South Carolina; results first posted 2018-06-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism. Trials, record NCT00920829. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00920829
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism
- NCT number
- NCT00920829
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 358 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Alcohol Dependence
- Interventions
- Naltrexone 50 Mg, Placebo
- First posted
- 2009-06-15
- Last updated
- 2018-07-10
- Results first posted
- 2018-06-04
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Heavy Drinking Days by mu Opioid Receptor Gene | Time Line Follow-Back drinking collected at each of 9 visits (weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Heavy Drinking Days by mu Opioid Receptor Gene | Time Line Follow-Back drinking collected at each of 9 visits (weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16) | percentage of days | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Heavy Drinking Days by mu Opioid Receptor Gene | A118G A/A With Naltrexone | Month 1 | 11.0 | Standard Error 3.5 | percentage of days |
| Percent Heavy Drinking Days by mu Opioid Receptor Gene | A118G A/A With Placebo | Month 1 | 18.0 | Standard Error 3.4 | percentage of days |
| Percent Heavy Drinking Days by mu Opioid Receptor Gene | A118G Any G With Naltrexone | Month 1 | 11.8 | Standard Error 3.4 | percentage of days |
| Percent Heavy Drinking Days by mu Opioid Receptor Gene | A118G Any G With Placebo | Month 1 | 18.7 | Standard Error 3.6 | percentage of days |
| Percent Heavy Drinking Days by mu Opioid Receptor Gene | A118G A/A With Naltrexone | Month 2 | 11.7 | Standard Error 4.5 | percentage of days |
| Percent Heavy Drinking Days by mu Opioid Receptor Gene | A118G A/A With Placebo | Month 2 | 25.8 | Standard Error 4.4 | percentage of days |
| Percent Heavy Drinking Days by mu Opioid Receptor Gene | A118G Any G With Naltrexone | Month 2 | 15.5 | Standard Error 4.4 | percentage of days |
| Percent Heavy Drinking Days by mu Opioid Receptor Gene | A118G Any G With Placebo | Month 2 | 19.7 | Standard Error 4.5 | percentage of days |
| Percent Heavy Drinking Days by mu Opioid Receptor Gene | A118G A/A With Naltrexone | Month 3 | 10.4 | Standard Error 4.4 | percentage of days |
| Percent Heavy Drinking Days by mu Opioid Receptor Gene | A118G A/A With Placebo | Month 3 | 23.0 | Standard Error 4.3 | percentage of days |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Allocation | STARTED | A118G A/A With Naltrexone | 38 | |
| Allocation | STARTED | A118G A/A With Placebo | 39 | |
| Allocation | STARTED | A118G Any G With Naltrexone | 38 | |
| Allocation | STARTED | A118G Any G With Placebo | 37 | |
| Allocation | COMPLETED | A118G A/A With Naltrexone | 35 | |
| Allocation | COMPLETED | A118G A/A With Placebo | 38 | |
| Allocation | COMPLETED | A118G Any G With Naltrexone | 38 | |
| Allocation | COMPLETED | A118G Any G With Placebo | 35 | |
| Allocation | NOT COMPLETED | A118G A/A With Naltrexone | 3 | |
| Allocation | NOT COMPLETED | A118G A/A With Placebo | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events16
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 | Nausea | Gastrointestinal disorders | Placebo/ASN | 9 | 38 | 9 |
| other | Nausea | Gastrointestinal disorders | Placebo/ASP | 9 | 35 | 14 |
| other | Nausea | Gastrointestinal disorders | Naltrexone/ASN | 22 | 35 | 27 |
| other | Nausea | Gastrointestinal disorders | Naltrexone/ASP | 13 | 38 | 26 |
| other | Diarrhea | Gastrointestinal disorders | Placebo/ASN | 6 | 38 | 8 |
| other | Diarrhea | Gastrointestinal disorders | Placebo/ASP | 9 | 35 | 19 |
| other | Diarrhea | Gastrointestinal disorders | Naltrexone/ASN | 18 | 35 | 28 |
| other | Diarrhea | Gastrointestinal disorders | Naltrexone/ASP | 16 | 38 | 35 |
| other | abdominal pain | Gastrointestinal disorders | Placebo/ASN | 4 | 38 | 6 |
| other | abdominal pain | Gastrointestinal disorders | Placebo/ASP | 5 | 35 | 17 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo/ASN | 0 | 38 |
| Total, all-cause mortality | Placebo/ASP | 0 | 35 |
| Total, all-cause mortality | Naltrexone/ASN | 0 | 35 |
| Total, all-cause mortality | Naltrexone/ASP | 1 | 38 |
| Total, other adverse events | Placebo/ASN | 16 | 38 |
| Total, other adverse events | Placebo/ASP | 20 | 35 |
| Total, other adverse events | Naltrexone/ASN | 30 | 35 |
| Total, other adverse events | Naltrexone/ASP | 29 | 38 |
| Total, serious adverse events | Placebo/ASN | 0 | 38 |
| Total, serious adverse events | Placebo/ASP | 0 | 35 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28409564 | RESULT |
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 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/NCT00920829
GET https://conductscience.org/api/trials/v1/NCT00920829/flow?page=2