This is a single-center, randomized intervention study in a volunteer population of patients with cocaine/crack use disorder to evaluate the pharmacological treatment of cocaine/crack craving, comparing the drug clonidine with the active placebo clonazepam.
Patients included will be administered clonidine 0.1 mg every 12 hours or clonazepam 0.25 mg every 12 hours for the first 2 weeks of treatment, followed by a washout for the final 2 weeks. The medication will be administered under the supervision of a member of the nursing staff. Patients will be monitored with vital signs three times a day to track changes that may be caused by the medication, such as reduced heart rate and hypotension. The primary outcome measure will be the change in cocaine craving at admission and two weeks after the start of treatment, using the visual analog scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Clonidine 0,1 mg bid
clonazepam 0,25 mg bid
Visual Analog Scale (VAS)
Visual Analog Scale for craving, ranging from 0 to 10, where 0 means no craving and 10 means maximum craving
Time frame: Daily from enrollment to end of treatment at 2 weeks; then after 30, 60 and 90 days after end of treatment
Adverse Effects
Spontaneous reports
Time frame: from the beginning of the intervention to 90 days after enrollment in the study
Blood pressure
Diastolic and systolic pressure in mmHg
Time frame: Three times daily from baseline up to 14 days
Heart Rate
Heart rate in beats per minute
Time frame: Three times daily from baseline up to 14 days
Cinical Global Impression - Severity of Illness (CGI-S)
The Clinical Global Impression - Severity of Illness (CGI-S) is a brief, clinician-rated scale used to assess the current severity of a patient's mental illness at the time of assessment, ranging from 1 (1 Normal, not at all ill) to 7 (Among the most extremely ill patients)
Time frame: At baseline
Clinical Global Impression - Improvement (CGI-I)
The Clinical Global Impression - Improvement (CGI-I) scale is a single-item, clinician-rated assessment tool used to measure the change in a patient's overall clinical condition since the baseline, ranging from 1 (very much improved) to 7 (Very much worse)
Time frame: Will be assessed after 1 and 2 weeks from baseline
Crack/Cocaine Use
The Timeline Followback (TFLB) will be used to measure the patient's average daily drug use in standardized units (e.g. Units, grams, or rocks of cocaine/crack)
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Time frame: 30, 60 and 90 days after the end of the intervention