Trial of Ibudilast for Methamphetamine Dependence

NCT01860807 | Completed Phase 2 Results DMC

• 2 other identifiers: 1R01DA035054-01R01DA035054
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to test the safety and potential efficacy of ibudilast to treat methamphetamine dependence. The study hypotheses are that ibudilast will reduce methamphetamine use and increase treatment retention more than placebo among patients seeking treatment for methamphetamine dependence. As HIV infection is a common complication of methamphetamine dependence, half of the participants will be HIV positive and the study will assess whether ibudilast also improves HIV related outcomes (e.g. medication adherence, CD4 count, risk behaviors).

Conditions

Methamphetamine Dependence; HIV Infection

Keywords

methamphetamine; ibudilast; HIV

Outcome Measures

Primary Outcomes (1)

• Methamphetamine Use

  End of treatment methamphetamine abstinence

  12 weeks

Study Arms (2)

Ibudilast

EXPERIMENTAL

Ibudilast 50 mg twice daily

Drug: Ibudilast

Placebo

PLACEBO COMPARATOR

matching placebo twice daily

Drug: Placebo

Interventions

Ibudilast DRUG

Ibudilast

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• years of age or older;
• meet DSM-IV-TR criteria for MA dependence (SCID verified);
• a MA-positive urine drug screen at one or more visit during the two week lead-in period;
• seeking treatment for MA problems;
• willing and able to comply with study procedures;
• provide written informed consent;
• English speaking
• reside within 35 miles of the clinical research site; and
• if female of childbearing potential, not pregnant or lactating and willing to use a medically reliable method of birth control during the trial (e.g., birth control pills, Depo-Provera, and/or condoms with spermicide).

You may not qualify if:

• a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active TB; unstable cardiac, renal, or liver disease; uncontrolled hypertension; unstable diabetes);
• CD4 count \< 50 cells/mm3 (suggestive of advanced HIV infection)
• AST, ALT, or GGT \> 3 times upper normal limit;
• A corrected QT of \> 450 msecs in men or \> 460 msec in women on at least two ECGs during the baseline period, or clinical risk factors for Torsades de Pointes (e.g. (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or requiring ongoing treatment with concomitant medication(s) with established risk of Torsades de Pointes (e.g. Amiodarone, Arsenic trioxide, Astemizole, Bepridil, Chloroquine, Chlorpromazine, Cisapride, Citalopram, Clarithromycin, Disopyramide, Dofetilide, Domperidone, Droperidol, Erythromycin, Flecainide, Halofantrine, Haloperidol, Ibutilide, Levomethadyl, Mesoridazine, Methadone, Moxifloxacin, Pentamidine, Pimozide, Probucol, Procainamide, Quinidine, Sotalol, Sparfloxacin, Terfenadine, Thioridazine, Vandetanib);
• current ongoing treatment with psychotropic medications (e.g., antidepressants, antipsychotics, antiepileptics, sedative/hypnotics, narcotic analgesics);
• a neurological disorder (e.g., organic brain disease, dementia) or a medical condition which would make study agent compliance difficult or which would compromise informed consent;
• a major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar disorder) as assessed by the SCID;
• attempted suicide in the past 3 years and/or serious suicidal intention or plan in the past year as assessed by the C-SSRS;
• currently on prescription medication that is contraindicated for use with IBUD including alpha or beta agonists, theophylline, or other sympathomimetics;
• current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR;
• alcohol dependence within the past year;
• greater than one urine specimens during the lead-in with a riboflavin concentration of \< 900 ng/ml as assessed via UV fluorescence;
• a history of sensitivity to IBUD; or
• any other circumstances that, in the opinion of the investigators, would compromise participant safety;
• current participation in another clinical trial.

Sponsors & Collaborators

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

Study Sites (1)

UCLA Vine Street Clinic

Los Angeles, California, 90038, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

ibudilast

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Study did not determine if ibudilast may help patients who have stopped methamphetamine use prior to starting medication

Results Point of Contact

• Title: Keith Heinzerling MD
• Organization: UCLA

kheinzerling@mednet.ucla.edu

310-319-4700

Study Officials

• Keith Heinzerling, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Residence

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 23, 2013
• Study Start: July 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 30, 2019
• Results First Posted: January 30, 2019

Record last verified: 2019-01

Locations

US (1)