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Prometa Pharmacotherapy for Methamphetamine Dependence

Primary Purpose

Drug Abuse, Drug Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Prometa
Placebo
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Abuse focused on measuring Methamphetamine Dependence, Pharmacotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • UCLA Integrated Substance Abuse Programs

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control Group

Prometa

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Abstinence across the duration of the study

Secondary Outcome Measures

Days of methamphetamine use
days of other drug use
cognitive functioning

Full Information

First Posted
November 29, 2005
Last Updated
January 20, 2016
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00260481
Brief Title
Prometa Pharmacotherapy for Methamphetamine Dependence
Official Title
Double-Blind, Placebo Controlled Trial of Prometa Pharmacotherapy for the Treatment of Methamphetamine Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse, Drug Dependence
Keywords
Methamphetamine Dependence, Pharmacotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Prometa
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prometa
Intervention Description
Medication protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient medications for 39 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient placebo medications for 39 days.
Primary Outcome Measure Information:
Title
Abstinence across the duration of the study
Time Frame
from screening to termination
Secondary Outcome Measure Information:
Title
Days of methamphetamine use
Time Frame
from screening to termination
Title
days of other drug use
Time Frame
from screening to termination
Title
cognitive functioning
Time Frame
comparison of pre- to post-treatment scores

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
UCLA Integrated Substance ABuse Programs
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Integrated Substance Abuse Programs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22082089
Citation
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. Erratum In: Addiction. 2012 Apr;107(4):860.
Results Reference
derived

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Prometa Pharmacotherapy for Methamphetamine Dependence

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