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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Clonazepam 0,25 mg |
|
| Intervention | Experimental | Clonidine 0,1 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clonidine | Drug | Clonidine 0,1 mg bid |
| |
| clonazepam 0,25 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | Visual Analog Scale for craving, ranging from 0 to 10, where 0 means no craving and 10 means maximum craving | Daily from enrollment to end of treatment at 2 weeks; then after 30, 60 and 90 days after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effects | Spontaneous reports | from the beginning of the intervention to 90 days after enrollment in the study |
| Blood pressure | Diastolic and systolic pressure in mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dangela Lassi | Contact | +551138032802 | dangela.lassi@hc.fm.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Dangela Lassi | University of São Paulo General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Perdizes | Recruiting | São Paulo | São Paulo | 05021-001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35448887 | Background | Roque Bravo R, Faria AC, Brito-da-Costa AM, Carmo H, Mladenka P, Dias da Silva D, Remiao F, On Behalf Of The Oemonom Researchers. Cocaine: An Updated Overview on Chemistry, Detection, Biokinetics, and Pharmacotoxicological Aspects including Abuse Pattern. Toxins (Basel). 2022 Apr 13;14(4):278. doi: 10.3390/toxins14040278. |
| Label | URL |
|---|---|
| United Nations Office on Drugs and Crime. Treatment of Stimulant Use Disorders: Current Practices and Promising Perspectives. | View source |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Drug |
clonazepam 0,25 mg bid |
|
| Three times daily from baseline up to 14 days |
| Heart Rate | Heart rate in beats per minute | 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) | 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) | 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) | 30, 60 and 90 days after the end of the intervention |
| Drug Misuse and Addiction. National Institute on Drug Abuse website | View source |
| D006571 |
| Heterocyclic Compounds |