Cocaine Dependence
Conditions
Keywords
Cocaine, crack, treatment, dependence, biperiden
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.
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.
Interventions
DRUGBiperiden
Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
DRUGPlacebo
Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
Sponsors
Nacional Conseling of Scientific Development and Technology
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Participant flow
Pre-assignment details
55 participants in the placebo group and 56 participants in the biperiden group.
Participants by arm
| Arm | Count |
|---|---|
| Biperiden 55 participants took biperidene for 2 months. | 56 |
| Placebo 55 participants took placebo for 2 months. | 55 |
| Total | 111 |
Baseline characteristics
| Characteristic | Biperiden | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 7.6 | 31.5 years STANDARD_DEVIATION 6.6 | 32.2 years STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 56 Participants | 55 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Brazil | 56 participants | 55 participants | 111 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 56 Participants | 55 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 56 |
| other Total, other adverse events | 0 / 55 | 0 / 56 |
| serious Total, serious adverse events | 0 / 55 | 0 / 56 |
Outcome results
Primary
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 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.
Time frame: 3 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biperiden | Compulsion | 5.9 score on a scale | Standard Deviation 2.6 |
| Placebo | Compulsion | 5.5 score on a scale | Standard Deviation 2.6 |
Comparison: We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.p-value: <0.05ANOVA