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View Clinical Trial (Medical Research Study)
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Quetiapine for the Reduction of Cocaine Use - NCT00631748-98493 (Clinical Trial 207373)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy207373.aspx
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| City: |
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Tacoma |
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State:
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WA |
| Zip Code: |
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98493 |
| Conditions: |
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Cocaine Dependence - Cocaine Abuse - Cocaine Addiction - Drug Abuse - Substance Abuse |
| Purpose: |
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This placebo-controlled trial will test the effectiveness of Seroquel XR™ for the treatment
of cocaine dependence in non-psychotic individuals who are cocaine dependent.
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| Study summary: |
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Cocaine abuse continues to be an epidemic. Co-morbid psychiatric disorders and high risks
behaviors compound the morbidity, economic costs, and social destruction associated with
this public health crisis. This is a 12 week, prospective, intent-to-treat, double-blind,
randomized, placebo-controlled study of Seroquel XR™ versus matched placebo, combined with
cognitive-behavioral group therapy, for the treatment of cocaine dependence in non-psychotic
individuals.
We will conduct this study at the American Lake (Tacoma) and Seattle campuses of the VA
Puget Sound Health Care System, recruiting veteran and non-veteran participants currently
using cocaine from the greater Pierce and King Counties region. It is anticipated that 120
subjects will be consented and screened for study participation and that 60 subjects will be
randomized to treatment.
After subjects have provided informed consent, they will enter a 1 week screening phase
during which medical, psychiatric, and substance use measures and assessments will be
administered to determine study eligibility. At baseline, we will assess cocaine use,
cocaine craving, psychiatric symptoms, and high risk behaviors. Also at this visit,
subjects will be randomly assigned to treatment with quetiapine (target dose 400 mg/day) or
placebo. During the treatment phase, subjects will visit the clinic once a week for safety
monitoring, completion of ratings and questionnaires, UDS's, and participation in a
cognitive-behavioral therapy group. At end of study, week 12, a physical examination will
be administered and a UDS and clinical laboratory values obtained. In addition, substance
use, psychiatric symptoms, and high risk behaviors will be assessed. To monitor safety and
further evaluate treatment effects, we will ask participants to return for a follow-up visit
at week 16. |
| Criteria: |
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Inclusion Criteria:
1. Provision of written informed consent
2. Males and females aged 18-65 years
3. Female subjects of childbearing potential must be using a reliable method of
contraception and have a negative urine human chorionic gonadotropin (HCG) test at
the screening and baseline visits and agree to use one of the following methods of
birth control: a) oral contraceptive, b) patch, c) intrauterine progesterone or
non-hormonal contraceptive system, d) levonorgestrel implant, e) medroxyprogesterone
acetate contraceptive injection, or f) complete abstinence from sexual intercourse
4. A diagnosis of current cocaine dependence; as determined by the Structured Clinical
Interview for DSM-IV-TR Axis I Disorders 69 (SCID-I/P)
5. Has used cocaine within the 30 days prior to screening
6. Able to understand and comply with the requirements of the study
7. Is seeking treatment for cocaine dependence
8. Is able to provide a reliable primary contact phone number and is able to provide a
reliable alternate contact address and phone number, such as for a relative or close
friend
9. Anticipates no life changes that would preclude study completion
Exclusion Criteria:
1. Pregnancy or lactation
2. Currently hospitalized or in a detoxification program
3. Physiological dependence on alcohol, sedative/hypnotic, or any other substance
requiring medical detoxification
4. Current diagnosis of psychotic disorder, including bipolar disorder with psychotic
features, as determined by the SCID-I/P or clinical interview
5. Subjects who are judged by the investigator to be psychiatrically unstable, including
posing an imminent risk of suicide or a danger to self or others, as determined by
the SCID-I/P, CGI-S, Hamilton Anxiety Rating Scale(HAM-A), Hamilton Rating Scale for
Depression(HAM-D), or clinical interview
6. Known intolerance or lack of response to quetiapine fumarate, as judged by the
investigator
7. Has a history of neuroleptic malignant syndrome or other serious adverse reaction to
antipsychotic medication
8. Use of any antipsychotic medication within the 30 days preceding baseline
9. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days prior to
baseline including but not limited to: ketoconazole, itraconazole, fluconazole,
erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir,
fluoxetine, fluvoxamine, paroxetine, and saquinavir
10. Use of any of the following cytochrome P450 inducers in the 14 days prior to baseline
including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St.
John's Wort, and glucocorticoids
11. Evidence of any clinically relevant disease (e.g., renal, hepatic, gastrointestinal,
pulmonary, cardiac, or cerebrovascular disease, AIDS, cancer, asthma, neurological or
neuromuscular disease, seizure disorder, or clinically significant abnormal
laboratory value) or any clinical finding that in the judgment of the investigator
could potentially be negatively affected by study participation or that could
potentially affect study participation |
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| Study is available at: |
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VA Puget Sound Health Care System
Tacoma, WA 98493
United States
Primary Contact:
Kennedy
Email: Annette.Kennedy@va.gov
Phone: 253-583-1614
Secondary Contact:
Annette Kennedy, Psy.D.
Email: Annette.Kennedy@va.gov
Phone: 253-583-1614 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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