Cocaine/Crack and Reduction of Compulsion With Biperiden
Study Details
Study Description
Brief 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. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Biperiden Thirty volunteers will take three pills of Biperiden (6mg/day) during two months. |
Drug: Biperiden
Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
Other Names:
|
| Placebo Comparator: Placebo Thirty volunteers will take three pills of Placebo (6mg/day) during two months. |
Drug: Placebo
Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)
Exclusion Criteria:
-
Being under treatment with psychoactive drugs
-
Have been diagnosed for other Psychiatric Disorders
-
Have dependence diagnosis for other drugs, except for tabacco
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UDED - Drug Dependence Unit | São Paulo | Brazil | 04024-003 |
Sponsors and Collaborators
- Federal University of São Paulo
- Nacional Conseling of Scientific Development and Technology
Investigators
- Principal Investigator: José C F. Galduróz, Universidade Federal de São Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACJC2010
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 55 participants in the placebo group and 56 participants in the biperiden group. |
| Arm/Group Title | Biperiden | Placebo |
|---|---|---|
| Arm/Group Description | Thirty volunteers will take three pills of Biperiden (6mg/day) during two months. Biperiden: Thirty volunteers will take three pills of Biperiden (6mg/day) during two months. | Thirty volunteers will take three pills of Placebo (6mg/day) during two months. Placebo: Thirty volunteers will take three pills of Placebo (6mg/day) during two months. |
| Period Title: Overall Study | ||
| STARTED | 56 | 55 |
| COMPLETED | 24 | 11 |
| NOT COMPLETED | 32 | 44 |
Baseline Characteristics
| Arm/Group Title | Biperiden | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | 55 participants took biperidene for 2 months. | 55 participants took placebo for 2 months. | Total of all reporting groups |
| Overall Participants | 56 | 55 | 111 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
32.9
(7.6)
|
31.5
(6.6)
|
32.2
(7.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
56
100%
|
55
100%
|
111
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
56
100%
|
55
100%
|
111
100%
|
| Not Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| Brazil |
56
100%
|
55
100%
|
111
100%
|
Outcome Measures
| Title | Compulsion |
|---|---|
| Description | 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. |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Biperiden | Placebo |
|---|---|---|
| Arm/Group Description | Thirty volunteers will take three pills of Biperiden (6mg/day) during two months. Biperiden: Thirty volunteers will take three pills of Biperiden (6mg/day) during two months. | Thirty volunteers will take three pills of Placebo (6mg/day) during two months. Placebo: Thirty volunteers will take three pills of Placebo (6mg/day) during two months. |
| Measure Participants | 56 | 55 |
| Mean (Standard Deviation) [score on a scale] |
5.9
(2.6)
|
5.5
(2.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Biperiden, Placebo |
|---|---|---|
| Comments | We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample. | |
| Type of Statistical Test | Equivalence | |
| Comments | The comparisons between the placebo and the biperiden groups at baseline were performed by means of the independent t-Test. We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample. We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack. | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack. | |
| Method | ANOVA | |
| Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Placebo | Biperiden | ||
| Arm/Group Description | No adverse event | No adverse event | ||
All Cause Mortality |
||||
| Placebo | Biperiden | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | 00/56 (0%) | ||
Serious Adverse Events |
||||
| Placebo | Biperiden | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 00/55 (0%) | 00/56 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo | Biperiden | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | 0/56 (0%) | ||
| Nervous system disorders | ||||
| 0/55 (0%) | 0/56 (0%) | |||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | PhD José Carlos F. Galduróz |
|---|---|
| Organization | Universidade Federal de São Paulo |
| Phone | |
| galduroz@unifesp.br |
- ACJC2010