Cocaine DependencePhase 3NCT01251393
Cocaine/Crack and Reduction of Compulsion With Biperiden
A Phase 3 study testing Biperiden in people with Cocaine Dependence, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Biperiden
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Nov 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)
Who cannot join
- Being under treatment with psychoactive drugs
- Have been diagnosed for other Psychiatric Disorders
- Have dependence diagnosis for other drugs, except for tabacco
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden
Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence.
Read the detailed description
Cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15 and 64 years old. The drug dependence has been described by many authors as a dysfunction of the brain reward system. Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. To accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be study. This is a double-blind controlled and randomized placebo study. All the patients will be treated with brief intervention therapy (BIT), and half of them will receive biperiden (6mg/day) while the other half will receive placebo. The treatment efficacy will be evaluated through the comparison between the values obtained on the following measures before and after the treatment: Craving scale of Minnesota and Cocaine/crack consumption questionnaire, and the presence of the cocaine metabolite (benzoylecgonine) on urine.
- Conditions
- Cocaine Dependence
- Being tested
- Biperiden, Placebo
- Keywords
- Cocaine, crack, treatment, dependence, biperiden
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiperidenDrug
Also called Group psychotherapy
Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
PlaceboDrug
Also called Group psychotherapy
Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
| Study group | Role | What they receive |
|---|---|---|
| Biperiden | Experimental | Thirty volunteers will take three pills of Biperiden (6mg/day) during two months. Receives: Drug: Biperiden |
| Placebo | Placebo comparator | Thirty volunteers will take three pills of Placebo (6mg/day) during two months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compulsion
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
- time/day - check: 1 point
- times/day - check: 2 points
- 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Nacional Conseling of Scientific Development and Technology
- Responsible party
- Principal investigator, Jose Carlos Fernandes Galduroz MD, Federal University of São Paulo
- Investigators
- José C F. Galduróz, Principal investigator, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251393
- Sponsor's protocol ID
- ACJC2010
- Status last verified
- Sep 2020
- First submitted
- 30 Nov 2010
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden
- ClinicalTrials.gov ID
- NCT01251393
- Acronym / sponsor ID
- ACJC2010
- Conditions
- Cocaine Dependence
- Keywords
- Cocaine, crack, treatment, dependence, biperiden
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Nacional Conseling of Scientific Development and Technology
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Posted 28 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence.
Detailed description
Cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15 and 64 years old. The drug dependence has been described by many authors as a dysfunction of the brain reward system. Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. To accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be study. This is a double-blind controlled and randomized placebo study. All the patients will be treated with brief intervention therapy (BIT), and half of them will receive biperiden (6mg/day) while the other half will receive placebo. The treatment efficacy will be evaluated through the comparison between the values obtained on the following measures before and after the treatment: Craving scale of Minnesota and Cocaine/crack consumption questionnaire, and the presence of the cocaine metabolite (benzoylecgonine) on urine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biperiden | Experimental | Drug: BiperidenThirty volunteers will take three pills of Biperiden (6mg/day) during two months. |
| Placebo | Placebo comparator | Drug: PlaceboThirty volunteers will take three pills of Placebo (6mg/day) during two months. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)
Key exclusion criteria (3 listed)
- Being under treatment with psychoactive drugs
- Have been diagnosed for other Psychiatric Disorders
- Have dependence diagnosis for other drugs, except for tabacco
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiperidenAlso: Group psychotherapyThirty volunteers will take three pills of Biperiden (6mg/day) during two months. | Drug | Biperiden |
| PlaceboAlso: Group psychotherapyThirty volunteers will take three pills of Placebo (6mg/day) during two months. | Drug | Placebo |
Primary outcome
Compulsion
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José C F. Galduróz principal investigator
Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biperiden in people with Cocaine Dependence, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compulsion (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.