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 individuals meeting criteria for methamphetamine abuse. It is hypothesized that individuals assigned to receive the PROMETA pharmacotherapy, compared to placebo, will demonstrate significantly fewer and less intense withdrawal symptoms, more days abstinent from methamphetamine use, and fewer relapses to methamphetamine use as assessed by self-report of drug use verified by urine samples.

Condition	Intervention	Phase
Drug Abuse Drug Dependence	Drug: Prometa	Phase II Phase III

Further study details as provided by University of California, Los Angeles:

Primary Outcomes: Abstinence across the duration of the study
Secondary Outcomes: Days of methamphetamine use; days of other drug use; cognitive functioning
Expected Total Enrollment:  90

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 combination of medications delivered both orally and by infusion in a controlled medical setting. Participants will be randomly assigned to the active medication or placebo condition, and will receive medications for 40 days, including two inpatient hospitalization phases of three days each. All participants will also receive once-weekly psychosocial cognitive-behavioral therapy throughout the 106 day study duration. A variety of data will be collected throughout the study, including psychological, cognitive, medical, and laboratory assessments.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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 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 (Klonapin TM) or other benzodiazepine;
• 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00260481

Walter Ling, M.D.      310-312-0500  Ext. 317    lwalter@ix.netcom.com
Maureen P. Hillhouse, Ph.D.      310-312-0500  Ext. 308    hillhous@ucla.edu

California
      UCLA Santa Monica Medical Center, Santa Monica,  California,  90025,  United States
      Mission Community Hospital, Panorama City,  California,  91402,  United States

Study chairs or principal investigators

Walter Ling, M.D.,  Principal Investigator,  UCLA Integrated Substance ABuse Programs   

Study ID Numbers:  05-01-076-01
Last Updated:  December 8, 2005
Record first received:  November 29, 2005
ClinicalTrials.gov Identifier:  NCT00260481
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10