Trial Outcomes & Findings for Cocaine/Crack and Reduction of Compulsion With Biperiden (NCT NCT01251393)

Last Updated: 2020-10-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

111 participants

Primary outcome timeframe

3 months

Results posted on

2020-10-14

Participant Flow

55 participants in the placebo group and 56 participants in the biperiden group.

Participant milestones

Participant milestones
Measure	Biperiden 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.	Placebo 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.
Overall Study STARTED	56	55
Overall Study COMPLETED	24	11
Overall Study NOT COMPLETED	32	44

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cocaine/Crack and Reduction of Compulsion With Biperiden

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biperiden n=56 Participants 55 participants took biperidene for 2 months.	Placebo n=55 Participants 55 participants took placebo for 2 months.	Total n=111 Participants Total of all reporting groups
Age, Continuous	32.9 years STANDARD_DEVIATION 7.6 • n=5 Participants	31.5 years STANDARD_DEVIATION 6.6 • n=7 Participants	32.2 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	55 Participants n=7 Participants	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants n=5 Participants	55 Participants n=7 Participants	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Brazil	56 participants n=5 Participants	55 participants n=7 Participants	111 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Biperiden n=56 Participants 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.	Placebo n=55 Participants 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.
Compulsion	5.9 score on a scale Standard Deviation 2.6	5.5 score on a scale Standard Deviation 2.6

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Biperiden

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=55 participants at risk No adverse event	Biperiden n=56 participants at risk No adverse event
Nervous system disorders	0.00% 0/55	0.00% 0/56

Additional Information

PhD José Carlos F. Galduróz

Universidade Federal de São Paulo

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place