Cocaine Use Disorder, Crack Abuse or Dependence
Conditions
Keywords
crack, cocaine, craving
Brief summary
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.
Detailed description
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.
Interventions
DRUGclonidine
Clonidine 0,1 mg bid
DRUGclonazepam 0,25 mg
clonazepam 0,25 mg bid
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients hospitalized in the adult Alcohol and Drugs ward of the Perdizes Institute (IPer) at the Hospital das Clínicas, University of São Paulo Medical School * DSM-5 criteria for cocaine and/or crack use disorder * Voluntarily seeking treatment * Must be able to swallow pills
Exclusion criteria
* Inability to read and/or understand the study questionnaires * benzodiazepine use disorder * opioid use disorder * alcohol use disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | Daily from enrollment to end of treatment at 2 weeks; then after 30, 60 and 90 days after end of treatment | Visual Analog Scale for craving, ranging from 0 to 10, where 0 means no craving and 10 means maximum craving |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Effects | from the beginning of the intervention to 90 days after enrollment in the study | Spontaneous reports |
| Blood pressure | Three times daily from baseline up to 14 days | Diastolic and systolic pressure in mmHg |
| Heart Rate | Three times daily from baseline up to 14 days | Heart rate in beats per minute |
| Cinical Global Impression - Severity of Illness (CGI-S) | At baseline | 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) |
| Clinical Global Impression - Improvement (CGI-I) | Will be assessed after 1 and 2 weeks from baseline | 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) |
| Crack/Cocaine Use | 30, 60 and 90 days after the end of the intervention | 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) |
Countries
Brazil
Contacts
CONTACTDangela Lassi
PRINCIPAL_INVESTIGATORDangela Lassi
University of São Paulo General Hospital
Outcome results
None listed