Safety Interaction Trial Ibudilast and Methamphetamine

NCT01217970 | Completed Phase 1 DMC

• 2 other identifiers: ShoptawPI_ibudilastR01DA029804
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan and South Korea, ibudilast has been used safely in humans as a treatment for asthma, pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in outpatient settings with people who have methamphetamine dependence. This would be the first study to collect this information. This study is important because individuals with methamphetamine dependence often relapse to meth use, even when in treatment; some number of individuals who participate in an outpatient study will relapse to methamphetamine while taking ibudilast. It is crucial to know whether there may be interactions between ibudilast and methamphetamine before planning an outpatient clinical trial.Ibudilast is an exciting medication candidate for treating methamphetamine dependence. When individuals become abstinent from methamphetamine during early recovery, the body starts an inflammatory process in neurons, especially glial cells. Glial cells are important in that they provide support to the nerve cells that are involved in thought, movement, and other human activities. By dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells during early abstinence, which in turn may help individuals feel better and think better during treatment. The study specific aims are to determine whether ibudilast alters:

1. 1.blood pressure and heart rate responses to methamphetamine;
2. 2.the ratings of craving or other drug experiences from methamphetamine;
3. 3.the reward/reinforcing effects of methamphetamine; and
4. 4.the metabolism of methamphetamine.

Conditions

Methamphetamine-dependence; Substance Abuse

Keywords

methamphetamine; dependence; stimulant; amphetamine; los angeles; meth; speed; crank; abuse

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Insomnia, Nicotine craving, Gastrointestinal upset, Headache, Musculoskeletal pain, Pain at IV site, Rash, Vivid dreams, Constipation, Dizziness, Dysuria, Ectopic heart beats, Fever/chills/hot flashes, Pruritis, Sore throat, Tinnitus, Backache, Chest congestion, Sedation, or other reported by patient or observed by clinician

  35 days

• Number of Participants with Clinically Significant Changes in Cardiovascular Parameters as a Measure of Safety and Tolerability

  Systolic and diastolic blood pressure, heart rate, and an EKG "rhythm strip"

  35 days

Secondary Outcomes (1)

• Number of participants with adverse outcomes on (1) VAS, drug-effect scale, subjective effects, etc., and (2) pharmacokinetics of methamphetamine as measures of efficacy

  35 days

Study Arms (2)

placebo, Ibudilast 20 mg, then Ibudilast 50mg

EXPERIMENTAL

Sequence: (1) Placebo, (2) Ibudilast 20 mg BID, then (3) Ibudilast 50 mg BID

Drug: Ibudilast 20mg; Drug: Ibudilast 50mg; Drug: Placebo oral tablet

Ibudilast 20 mg, Ibudilast 50mg, then placebo

EXPERIMENTAL

Sequence: (1) Ibudilast 20 mg BID, (2) Ibudilast 50 mg BID, then (3) Placebo

Drug: Ibudilast 20mg; Drug: Ibudilast 50mg; Drug: Placebo oral tablet

Interventions

Ibudilast 20mg DRUG

Ibudilast 20mg BID

Also known as: IBUD

Ibudilast 20 mg, Ibudilast 50mg, then placebo; placebo, Ibudilast 20 mg, then Ibudilast 50mg

Ibudilast 50mg DRUG

Ibudilast 50mg BID

Also known as: IBUD

Ibudilast 20 mg, Ibudilast 50mg, then placebo; placebo, Ibudilast 20 mg, then Ibudilast 50mg

Placebo oral tablet DRUG

Also known as: Placebo

Ibudilast 20 mg, Ibudilast 50mg, then placebo; placebo, Ibudilast 20 mg, then Ibudilast 50mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• NOT seeking treatment for methamphetamine problems;
• English-speaking;
• Age 18-55;
• Meet SCID criteria for MA dependence;
• Self-reported history of MA use via injection or smoking AND at least one MA positive urine drug screening during eligibility;
• Resting heart rate 50-100BPM; Systolic BP 105-150 mm Hg; Diastolic BP 45-90 mm Hg stabilized within 2 days of admission;
• Baseline EKG demonstrating normal sinus rhythm, normal conduction, no clinically significant arrhythmias;
• Use of acceptable barrier method of birth control;
• If female, not pregnant or lactating;
• Have medical history and physical examination demonstrating no additional clinically significant contraindications for study participation, in judgment of investigators.

You may not qualify if:

• Current dependence on cocaine, opioids, marijuana, or alcohol;
• Liver function tests GE 3x upper limit of normal, or kidney function tests GE 2x the upper limit of normal;
• Current or past history of seizure disorder;
• History of head trauma;

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator
• MediciNova: collaborator

Study Sites (1)

Harbor-UCLA Medical Center GCRC

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

ibudilast

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Steven Shoptaw, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 8, 2010
• Study Start: January 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

US (1)