Drug AbusePhase 2/3NCT00260481

Prometa Pharmacotherapy for Methamphetamine Dependence

A Phase 2/3 study testing Prometa in people with Drug Abuse and Drug Dependence, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Drug Abuse, Drug Dependence
What is being tested?: Prometa
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteUnited States
Study dates: Jan 2006to Jun 2008
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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. -

Who cannot join

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;

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA Integrated Substance Abuse Programs
Los Angeles, California, 90025

Other trials in United States

About this study

Official title: Double-Blind, Placebo Controlled Trial of Prometa Pharmacotherapy for the Treatment of Methamphetamine Abuse

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.

Read the 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.

Conditions: Drug Abuse, Drug Dependence
Being tested: Prometa, Placebo
Keywords: Methamphetamine Dependence, Pharmacotherapy
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00260481
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Prometa

What is being measured

The primary outcome is the main question the study is designed to answer.

Abstinence across the duration of the study
Measured: from screening to termination

Secondary outcomes (3)

Days of methamphetamine use
Measured: from screening to termination
days of other drug use
Measured: from screening to termination
cognitive functioning
Measured: comparison of pre- to post-treatment scores

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Jun 2008

First posted1 Dec 2005 (estimated)
Study startJan 2006
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Drug AbuseStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00260481
Sponsor's protocol ID: 05-01-076-01
Status last verified: Jan 2016
First submitted: 29 Nov 2005
Last updated: 22 Jan 2016
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 22082089

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-Blind, Placebo Controlled Trial of Prometa Pharmacotherapy for the Treatment of Methamphetamine Abuse
ClinicalTrials.gov ID: NCT00260481
Acronym / sponsor ID: 05-01-076-01
Conditions: Drug Abuse, Drug Dependence
Keywords: Methamphetamine Dependence, Pharmacotherapy
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Study start: Jan 2006
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 1 Dec 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control Group	Placebo comparator	Drug: PlaceboDuring 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.
Prometa	Active comparator	Drug: PrometaDuring 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (18 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PrometaMedication protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient medications for 39 days	Drug	Prometa
PlaceboPlacebo protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient placebo medications for 39 days.	Drug	Control Group

Primary outcome

Abstinence across the duration of the study
Time frame: from screening to termination

3 secondary outcomes

Days of methamphetamine use
Time frame: from screening to termination
days of other drug use
Time frame: from screening to termination
cognitive functioning
Time frame: comparison of pre- to post-treatment scores

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
Derived from this study: PubMed 22082089Ling 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Walter Ling, M.D. principal investigator

UCLA Integrated Substance ABuse Programs

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Prometa in people with Drug Abuse and Drug Dependence, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abstinence across the duration of the study (time frame: from screening to termination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00260481, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2016.