Status:
COMPLETED
Prometa Pharmacotherapy for Methamphetamine Dependence
Lead Sponsor:
University of California, Los Angeles
Conditions:
Drug Abuse
Drug Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy of the PROMETA pharmacotherapy compared to placebo for initiating abstinence and for preventing relapse to methamphetamine use in treatment-seeking ...
Detailed Description
Using a double-blind placebo design, the effectiveness of the Prometa protocol for methamphetamine dependence will be investigated as compared to a placebo condition. The procedure utilizes a combinat...
Eligibility Criteria
Inclusion
- Be at least 18 years-of-age;
- Have a DSM-IV-TR diagnosis of methamphetamine abuse or dependence as determined by SCID;
- Be seeking treatment for methamphetamine abuse or dependence;
- Be able to understand, and having understood, provide written informed consent;
- If female and of child bearing potential, agree to use an approved method of birth control or be surgically sterile;
- Have completed all other psychological assessments; -Have used methamphetamine at least 4 of the last 30 days. -
Exclusion
- Have current dependence, defined by DSM-IV-TR criteria, on any psychoactive substance other than methamphetamine, alcohol, nicotine, or marijuana or physiological dependence on alcohol requiring medical detoxification (CIWA-AR score ≥ 15);
- Be mandated by the court to obtain treatment for methamphetamine-abuse or dependence;
- Be anyone who, in the opinion of the investigator, would not be expected to complete the study protocol due to probable incarceration or relocation from the clinic area;
- Have a current or previous psychiatric, or a neurological disorder including but not limited to epilepsy and absence seizures, fainting spells, brain disease, dementia, or any disorder that, in the opinion of the study physician requires ongoing treatment that would make study participation unsafe or which would make treatment compliance difficult.
- Have a psychiatric disorder, as assessed by the SCID, or a neurological disorder including but not limited to epilepsy and absence seizures, brain disease, dementia or any disorder that, in the opinion of the study physician, requires ongoing treatment that would make study participation unsafe or which would make treatment compliance difficult;
- Have had electroconvulsive therapy within the past 3 months preceding screening; Have current suicidal ideation or plan (within the past 30 days) as assessed by the SCID;
- Be pregnant or lactating;
- Have serious medical illnesses (including, but not limited to: uncontrolled hypertension, significant heart disease including myocardial infarction within one year of enrollment, or any clinically significant cardiovascular abnormality (ECG), hepatic, renal or gastrointestinal disorders that could result in a clinically significant alteration of metabolism or excretion of the study agent, potentially life-threatening or progressive medical illness other than addiction that may compromise subject safety or study conduct);
- Have clinically significant abnormal laboratory values;
- Benzodiazepine and/or similar sedative-hypnotic or anxiolytic use or abuse within 15 days of potential PROMETA Treatment;
- Must not be habituated to benzodiazepines and must provide a urine sample that is negative for benzodiazepines;
- Must not be taking supra-therapeutic doses of zolpidem (Ambien TM) or zaleplon (Sonata TM); Taking clonazepam (Klonopin TM) or other benzodiazepine;
- Patients must not be taking cyclic antidepressants, lithium, methylxanthines, isoniazid, propoxyphene, monoamine oxidase inhibitors, buproprion HCL, and cyclosporine.
- Have AIDS;
- Have active tuberculosis (positive tuberculin test and confirmatory diagnostic chest x-ray);
- Have known or suspected hypersensitivity to PROMETA;
- Have been treated with PROMETA for any reason currently or during the past year;
- Have any disorder or condition that, in the opinion of the study physician, would make study participation difficult or unsafe.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00260481
Start Date
January 1 2006
End Date
June 1 2008
Last Update
January 22 2016
Active Locations (1)
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1
UCLA Integrated Substance Abuse Programs
Los Angeles, California, United States, 90025