Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232336
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2005-09-30
Brief Title:
Quetiapine for Cocaine Use and Cravings
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Organization:
Seattle Institute for Biomedical and Clinical Research
Study Overview
Official Title:
Efficacy of Quetiapine in the Reduction of Cocaine Use and Cravings in Individuals With Cocaine Dependence
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to collect pilot data on whether quetiapine may be effective in the reduction of cocaine use and cravings in cocaine dependent individuals
Detailed Description:
Dopaminergic and serotonergic neurotransmitter systems are involved in cocaine use and cravings Atypical antipsychotics act on these neurotransmitter systems and therefore may be beneficial in the treatment of cocaine addiction This open label study assessed the efficacy of quetiapine for the treatment of cocaine use and craving in non-psychotic cocaine dependent participants over 6 weeks of treatment The primary outcome measures included self-report of cocaine use and self-report of cocaine cravings This study also evaluated whether the severity of addiction predicts quetiapine efficacy
Males and females ages 18 - 65 with a DSM IV diagnosis of cocaine dependence were recruited for an open label trial of quetiapine dosed at 300-600 mgday with a target dose of 600 mgday Subjects were followed at weekly study visits to monitor general psychiatric and physical status medication compliance efficacy and adverse events Study participation included psychiatric and medical examinations an electrocardiogram an eye exam laboratory tests urine drug screens electrocardiograms and psychiatric and substance abuse interviews
Twenty-three males were initiated on quetiapine treatment the following results include the first twenty-two study completers Twenty-two males 36-56 years diagnosed with cocaine dependence without a psychotic disorder were initiated on a six-week open-label trial of quetiapine 300-600 mgday QHS Five participants discontinued prior to completing the first week of treatment and 14 of 22 subjects completed the study The mean dose of quetiapine was 429 mgday An intent-to-treat analysis found a significant decrease in cravings on the Brief Substance Craving Scale after six weeks p 001 Cohens d 123 repeated measures mixed effects random regression Cocaine use addiction severity and psychopathology also decreased numerically but not statistically from baseline to end of study Adverse effects were generally mild Addiction severity did not predict quetiapine efficacy Four subjects withdrew due to sedation 2 were discontinued by the investigators and 2 were lost to follow up Study completers experienced a statistically significant mean weight gain of approximately 460 95 CI -605 - 317 kgmean baseline weight 869 SD 1838 kg
Quetiapine treatment appears to have improved cocaine dependence specifically cocaine cravings in non-psychotic individuals The observed weight change may reflect both weight gain associated with cocaine dependence and medication side effect Controlled research is warranted to better define the potential role for quetiapine in the treatment of cocaine dependence
Males and females ages 18 - 65 with a DSM IV diagnosis of cocaine dependence were recruited for an open label trial of quetiapine dosed at 300-600 mgday with a target dose of 600 mgday Subjects were followed at weekly study visits to monitor general psychiatric and physical status medication compliance efficacy and adverse events Study participation included psychiatric and medical examinations an electrocardiogram an eye exam laboratory tests urine drug screens electrocardiograms and psychiatric and substance abuse interviews
Twenty-three males were initiated on quetiapine treatment the following results include the first twenty-two study completers Twenty-two males 36-56 years diagnosed with cocaine dependence without a psychotic disorder were initiated on a six-week open-label trial of quetiapine 300-600 mgday QHS Five participants discontinued prior to completing the first week of treatment and 14 of 22 subjects completed the study The mean dose of quetiapine was 429 mgday An intent-to-treat analysis found a significant decrease in cravings on the Brief Substance Craving Scale after six weeks p 001 Cohens d 123 repeated measures mixed effects random regression Cocaine use addiction severity and psychopathology also decreased numerically but not statistically from baseline to end of study Adverse effects were generally mild Addiction severity did not predict quetiapine efficacy Four subjects withdrew due to sedation 2 were discontinued by the investigators and 2 were lost to follow up Study completers experienced a statistically significant mean weight gain of approximately 460 95 CI -605 - 317 kgmean baseline weight 869 SD 1838 kg
Quetiapine treatment appears to have improved cocaine dependence specifically cocaine cravings in non-psychotic individuals The observed weight change may reflect both weight gain associated with cocaine dependence and medication side effect Controlled research is warranted to better define the potential role for quetiapine in the treatment of cocaine dependence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRUS QUET0297 | None | None | None |