Trial · NCT01251393
Cocaine/Crack and Reduction of Compulsion With Biperiden
NCT01251393, Phase 3, Completed, Federal University of São Paulo; results first posted 2020-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cocaine/Crack and Reduction of Compulsion With Biperiden. Trials, record NCT01251393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01251393
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cocaine/Crack and Reduction of Compulsion With Biperiden
- NCT number
- NCT01251393
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 111 participants, actual
- Lead sponsor
- Federal University of São Paulo
- Conditions
- Cocaine Dependence
- Interventions
- Biperiden, Placebo
- First posted
- 2010-12-01
- Last updated
- 2020-10-14
- Results first posted
- 2020-02-28
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compulsion | 3 months | The patients answered the Minnesota Cocaine Craving Scale (Halikas et al., 1991). INTENSITY: Evaluation of crack strength by cocaine in the previous week: Zero (no craving)---------------------------- -----10 (Intense craving) Ranges from 0 to 10 (zero = no craving; 10 intense craving). Using a rule starting from 0, we determine the number that corresponds to the compulsion. The farther from 0 the more intense the compulsion will be. Frequency of craving onset: How many times a day 0 time/day - check: 0 point 1. time/day - check: 1 point 2. times/day - check: 2 points 3. to 5 times/day - check: 3 points 6 to 10 times/day - check: 4 points 11 to 20 times/day - check: 5 points more than 20 times/day - check: 6 points Ranges from 0 to 6 points (zero = no craving; 1-2 points: Light; 3-4 points: moderate; 5- 6: intense craving). The sum of the points of the subscales provides the final score. |
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 | Compulsion | 3 months | A total sample of 166 patients was evaluated during the project. Of that number, 55 did not fulfil the inclusion criteria. The main reasons for exclusion were the presence of clinical comorbidities (active hepatitis, tuberculosis under treatment and epilepsy) or psychiatric comorbidities. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Compulsion | Biperiden | 5.9 | Standard Deviation 2.6 | score on a scale | |
| Compulsion | Placebo | 5.5 | Standard Deviation 2.6 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Biperiden | 56 | |
| Overall Study | STARTED | Placebo | 55 | |
| Overall Study | COMPLETED | Biperiden | 24 | |
| Overall Study | COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Biperiden | 32 | |
| Overall Study | NOT COMPLETED | Placebo | 44 |
Source ClinicalTrials.gov
Adverse events2
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 | Nervous system disorders | Placebo | 0 | 55 | ||
| other | Nervous system disorders | Biperiden | 0 | 56 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 55 |
| Total, all-cause mortality | Biperiden | 0 | 56 |
| Total, other adverse events | Placebo | 0 | 55 |
| Total, other adverse events | Biperiden | 0 | 56 |
| Total, serious adverse events | Placebo | 0 | 55 |
| Total, serious adverse events | Biperiden | 0 | 56 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Biperiden vs Placebo: deaths from any cause | Trial comparisons |
| Biperiden vs Placebo: 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/NCT01251393
GET https://conductscience.org/api/trials/v1/NCT01251393/registered