Prometa Pharmacotherapy for Methamphetamine Dependence

NCT00260481 | Completed Phase 2 DMC

• 1 other identifier: 05-01-076-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Drug Abuse; Drug Dependence

Keywords

Methamphetamine Dependence; Pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• Abstinence across the duration of the study

  from screening to termination

Secondary Outcomes (3)

• Days of methamphetamine use

  from screening to termination

• days of other drug use

  from screening to termination

• cognitive functioning

  comparison of pre- to post-treatment scores

Study Arms (2)

Control Group

PLACEBO COMPARATOR

During the Infusion periods, participants in the placebo condition will receive pre-treatment with hydroxyzine (50mg) followed by placebo medications administered both orally and through infusion, as well as a second dose of hydroxyzine (50mg), delivered at the same rate and delivery system to match the active condition. All participants may receive daily multivitamins as determined appropriate by the study physician. Multivitamins are not considered active medications for the PROMETA pharmacotherapy, but may be provided to participants in both conditions at the same rates and delivery methods for the duration of the study. Because participants are treatment-seeking and use of a placebo condition is warranted, all participants will be provided with once weekly, manual-guided cognitive behavioral therapy sessions during all outpatient periods of the study.

Drug: Placebo

Prometa

ACTIVE COMPARATOR

During the infusion periods, participants assigned to the PROMETA pharmacotherapy condition will receive pre-treatment with hydroxyzine (50mg) followed by intravenous flumazenil (2mg) over a 2-hour period. Before bedtime, patients will again take 50mg of hydroxyzine orally, as well as 300mg of oral gabapentin (participants will titrate up their dosage of gabapentin each day - 300mg on day 0, 600mg on day 1, 900mg on day 2). All participants may receive daily multivitamins as determined appropriate by the study physician. Multivitamins are not considered active medications for the PROMETA pharmacotherapy, but may be provided to participants in both conditions at the same rates and delivery methods for the duration of the study. Because participants are treatment-seeking and use of a placebo condition is warranted, all participants will be provided with once weekly, manual-guided cognitive behavioral therapy sessions during all outpatient periods of the study.

Drug: Prometa

Interventions

Prometa DRUG

Medication protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient medications for 39 days

Prometa

Placebo DRUG

Placebo protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient placebo medications for 39 days.

Control Group

Eligibility Criteria

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

You may qualify if:

• 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. -

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Integrated Substance Abuse Programs

Los Angeles, California, 90025, United States

Location

Related Publications (1)

• Ling W, Shoptaw S, Hillhouse M, Bholat MA, Charuvastra C, Heinzerling K, Chim D, Annon J, Dowling PT, Doraimani G. Double-blind placebo-controlled evaluation of the PROMETA protocol for methamphetamine dependence. Addiction. 2012 Feb;107(2):361-9. doi: 10.1111/j.1360-0443.2011.03619.x. Epub 2011 Nov 15.

  PMID: 22082089 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Walter Ling, M.D.

  UCLA Integrated Substance ABuse Programs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: January 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 22, 2016

Record last verified: 2016-01

Locations

US (1)