Quetiapine for the Reduction of Cocaine Use

NCT00631748 | Completed Results DMC

• 2 other identifiers: TA1 42IRUSQUET0449
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence; Cocaine Abuse; Cocaine Addiction; Drug Abuse; Substance Abuse

Keywords

cocaine; quetiapine fumarate; dependence; abuse; addiction; treatment

Outcome Measures

Primary Outcomes (1)

• Timeline Followback Interview (TLFB)

  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.

  Grams of cocaine used at end of study (12-weeks)

Secondary Outcomes (1)

• Percentage of Participants Attaining Abstinence for Three Weeks

  Abstinence defined as negative UDS for 3 consecutive weeks of the trial

Study Arms (2)

Study Drug

EXPERIMENTAL

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.

Drug: quetiapine fumarate; Behavioral: Cognitive-behavioral Therapy

Placebo

PLACEBO COMPARATOR

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.

Drug: Matched Placebo; Behavioral: Cognitive-behavioral Therapy

Interventions

quetiapine fumarate DRUG

At baseline, subjects in the experimental group will initially be administered 50 mg/day of Seroquel XR™ (extended release formulation of quetiapine fumarate), to be titrated up to 400 mg/day of Seroquel XR™ by the end of the second week. By the end of week 2, subjects will be stabilized on a dose of 400 mg/day or alternatively 300, 200, 100, or 50 mg/day of study drug, as tolerated. If a subject is unable to tolerate the 50 mg/day dose, he or she will be discontinued from the drug portion of the study.

Also known as: Seroquel XR

Study Drug

Matched Placebo DRUG

Subjects randomized to the placebo comparator group will follow the same titration and dosing procedures as the experimental group, but will receive matched placebo tablets.

Placebo

Cognitive-behavioral Therapy BEHAVIORAL

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; Study Drug

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• Males and females aged 18-65 years
• 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
• A diagnosis of current cocaine dependence; as determined by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders 69 (SCID-I/P)
• Has used cocaine within the 30 days prior to screening
• Able to understand and comply with the requirements of the study
• Is seeking treatment for cocaine dependence
• 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
• Anticipates no life changes that would preclude study completion

You may not qualify if:

• Pregnancy or lactation
• Currently hospitalized or in a detoxification program
• Physiological dependence on alcohol, sedative/hypnotic, or any other substance requiring medical detoxification
• Current diagnosis of psychotic disorder, including bipolar disorder with psychotic features, as determined by the SCID-I/P or clinical interview
• 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
• Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
• Has a history of neuroleptic malignant syndrome or other serious adverse reaction to antipsychotic medication
• Use of any antipsychotic medication within the 30 days preceding baseline
• 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
• 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
• 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

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• VA Puget Sound Health Care System: collaborator
• AstraZeneca: collaborator

Study Sites (1)

VA Puget Sound Health Care System

Tacoma, Washington, 98493, United States

Location

Related Publications (1)

• Kennedy A, Wood AE, Saxon AJ, Malte C, Harvey M, Jurik J, Kilzieh N, Lofgreen C, Tapp A. Quetiapine for the treatment of cocaine dependence: an open-label trial. J Clin Psychopharmacol. 2008 Apr;28(2):221-4. doi: 10.1097/JCP.0b013e318166f50d.

  PMID: 18344735 BACKGROUND

Related Links

• Website for Seeking Safety

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders; Behavior, Addictive

Interventions

Quetiapine Fumarate; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

1\) High number of drop-outs (68%) means that analyses are limited by a lack of power. 2) More males than females included-may reflect differences in cocaine drug usage between the sexes.

Results Point of Contact

• Title: Andre Tapp, MD
• Organization: VA Puget Sound Health Care System

andre.tapp@va.gov

253-589-4176

Study Officials

• Andre M Tapp, MD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 10, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 31, 2014
• Results First Posted: February 12, 2014

Record last verified: 2014-03

Locations

US (1)