Quetiapine for the Reduction of Cocaine Use

Not Applicable

Completed

• Conditions: Cocaine Dependence; Cocaine Abuse; Cocaine Addiction; Drug Abuse; Substance Abuse
• Interventions: Drug: Matched Placebo; Drug: quetiapine fumarate; Behavioral: Cognitive-behavioral Therapy

• Registration Number: NCT00631748
• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-10
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-12-16
• Results First Submitted QC: 2013-12-26
• Results First Posted: 2014-02-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-03
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Drug	Cognitive-behavioral Therapy	Subjects randomized to the experimental arm of the study will be initially administered 50mg/day quetiapine fumarate (Seroquel XR) to be titrated up to 400mg/day by the end of the second week. Subjects will be stabilized at a dose of 400mg/day or alternatively 300, 200, 100, or 50mg/day or quetiapine fumarate as tolerated. During the 12 week treatment phase, all subjects attended weekly group cognitive-behavioral therapy sessions. This therapy platform utilized the cognitive-behavioral therapy manual, Seeking Safety. Seeking Safety has been shown to effectively reduce substance use and to improve psychological functioning in a variety of populations.
Placebo	Matched Placebo	Subjects randomized to the placebo arm of the study will follow the same titration and dosing procedure as the experimental arm but will receive matched placebo tablets. During the 12 week treatment phase, all subjects attended weekly group cognitive-behavioral therapy sessions. This therapy platform utilized the cognitive-behavioral therapy manual, Seeking Safety. Seeking Safety has been shown to effectively reduce substance use and to improve psychological functioning in a variety of populations.
Placebo	Cognitive-behavioral Therapy	Subjects randomized to the placebo arm of the study will follow the same titration and dosing procedure as the experimental arm but will receive matched placebo tablets. During the 12 week treatment phase, all subjects attended weekly group cognitive-behavioral therapy sessions. This therapy platform utilized the cognitive-behavioral therapy manual, Seeking Safety. Seeking Safety has been shown to effectively reduce substance use and to improve psychological functioning in a variety of populations.
Study Drug	quetiapine fumarate	Subjects randomized to the experimental arm of the study will be initially administered 50mg/day quetiapine fumarate (Seroquel XR) to be titrated up to 400mg/day by the end of the second week. Subjects will be stabilized at a dose of 400mg/day or alternatively 300, 200, 100, or 50mg/day or quetiapine fumarate as tolerated. During the 12 week treatment phase, all subjects attended weekly group cognitive-behavioral therapy sessions. This therapy platform utilized the cognitive-behavioral therapy manual, Seeking Safety. Seeking Safety has been shown to effectively reduce substance use and to improve psychological functioning in a variety of populations.

Primary Outcome Measures

Name	Time	Method
Timeline Followback Interview (TLFB)	Grams of cocaine used at end of study (12-weeks)	The primary outcome measure was the self-report of cocaine use in the past week, as assessed with a Timeline Followback Interview (TLFB). The TLFB is a questionnaire in which the subject is asked to self-report how much cocaine was used and how much money was spent on cocaine every day for the past 1-2 weeks.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Attaining Abstinence for Three Weeks	Abstinence defined as negative UDS for 3 consecutive weeks of the trial	Abstinence was defined as a negative urine drug screen (UDS) (for cocaine) for three consecutive weeks of the trial measure at either time point Week 6 or Week 12

Trial Locations

Locations (1)

VA Puget Sound Health Care System; 🇺🇸 Tacoma, Washington, United States