Trial of Ibudilast for Methamphetamine Dependence (IBUD ph II)
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ClinicalTrials.gov Identifier: NCT01860807 |
Recruitment Status :
Completed
First Posted : May 23, 2013
Results First Posted : January 30, 2019
Last Update Posted : January 30, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Methamphetamine Dependence HIV Infection | Drug: Ibudilast Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 125 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized Trial of Ibudilast for Methamphetamine Dependence |
Study Start Date : | July 2013 |
Actual Primary Completion Date : | December 31, 2017 |
Actual Study Completion Date : | December 31, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Ibudilast
Ibudilast 50 mg twice daily
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Drug: Ibudilast |
Placebo Comparator: Placebo
matching placebo twice daily
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Drug: Placebo |
- Methamphetamine Use [ Time Frame: 12 weeks ]End of treatment methamphetamine abstinence

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 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).
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860807
United States, California | |
UCLA Vine Street Clinic | |
Los Angeles, California, United States, 90038 |
Principal Investigator: | Keith Heinzerling, MD | University of California, Los Angeles |
Documents provided by Keith Heinzerling, University of California, Los Angeles:
Responsible Party: | Keith Heinzerling, Associate Professor in Residence, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT01860807 |
Other Study ID Numbers: |
1R01DA035054-01 ( U.S. NIH Grant/Contract ) R01DA035054 ( U.S. NIH Grant/Contract ) |
First Posted: | May 23, 2013 Key Record Dates |
Results First Posted: | January 30, 2019 |
Last Update Posted: | January 30, 2019 |
Last Verified: | January 2019 |
methamphetamine ibudilast HIV |
HIV Infections 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 Ibudilast Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Vasodilator Agents |