Effect of Methamphetamine on Residual Latent HIV Disease Study (EMRLHD)
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ClinicalTrials.gov Identifier: NCT03825536 |
Recruitment Status :
Recruiting
First Posted : January 31, 2019
Last Update Posted : March 23, 2022
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Condition or disease | Intervention/treatment | Phase |
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HIV-1-infection Methamphetamine-dependence | Drug: Oral Methamphetamine Other: Placebo oral capsule | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | This is a phase IV open label randomized, double-blinded, placebo-controlled crossover study. A placebo treatment arm will be assigned to participants in a randomized crossover design. HIV+ ART-suppressed individuals with no prior history of MA use disorder will be administered 10mg oral methamphetamine hydrochloride, followed by 15 mg methamphetamine hydrochloride two hours later, for a total of 25mg in one 24-hour period (the maximum FDA approved daily dose for the treatment of childhood obesity). Participants will complete the study twice (once on a placebo treatment arm and once with the oral methamphetamine treatment arm). Which treatment arm occurs first will be randomly assigned and will include a 31-day washout period between the two phases. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | The order in which participants complete the two treatment phases (i.e., oral methamphetamine and placebo) will be unknown to both the participants and the PI/study team. Both the oral methamphetamine and placebo will be prepared in identical capsules by the UCSF investigational pharmacist, out of sight of the study participant, study coordinator, and study site PI and administered to the participant to maintain double blinding. The investigational pharmacist will randomize each participant according to the methods described above. In the event that participant experiences an adverse event that requires the identity of the study drug be revealed, the PI will be able to contact the investigational pharmacist to break the blind. In the event that a participant blind is broken, the study PIs will determine the impact upon the un-blinded participant's continued participation in the study and if a replacement participant is needed on a case-by-case basis. |
Primary Purpose: | Basic Science |
Official Title: | Short-term Effects of Methamphetamine Exposure on Residual Viral Transcription During Treated HIV Disease |
Actual Study Start Date : | January 1, 2021 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | June 30, 2023 |

Arm | Intervention/treatment |
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Experimental: Oral methamphetamine
Participants will be randomized to either oral methamphetamine versus placebo treatment first using a random number generator. Whichever treatment the participant receives first, they will receive the other treatment (placebo or oral methamphetamine) for their second treatment phase starting at approximately Day 77. For the experimental treatment arm, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later.
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Drug: Oral Methamphetamine
In this phase IV open label double-blind randomized crossover study, participants will be randomized to either of two treatment arms, oral methamphetamine or placebo, using a crossover design with a 31-day washout period in between treatment arms. For the oral methamphetamine treatment arm, an initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
Other Name: Desoxyn |
Placebo Comparator: Placebo oral capsule
Participants will be randomized to either oral methamphetamine versus placebo treatment first using a random number generator. Whichever treatment the participant receives first, they will receive the other treatment (placebo or oral methamphetamine) for their second treatment phase starting at approximately Day 77. For the placebo treatment arm, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
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Other: Placebo oral capsule
In this phase IV open label double-blind randomized crossover study, participants will be randomized to either of two treatment arms, oral methamphetamine or placebo, using a crossover design with a 31-day washout period in between treatment arms. For placebo treatment phase, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
Other Name: Placebo |
- HIV transcription (cell-associated HIV RNA) in peripheral blood [ Time Frame: 4 hours ]The change in HIV reservoir size (as measured by cell-associated HIV RNA levels) over a 4 hour study period.
- Systemic inflammation (plasma pro-inflammatory cytokine levels) [ Time Frame: 4 hours ]The change in systemic inflammation (plasma pro-inflammatory cytokine levels) over a 4 hour study period.
- Host gene expression (RNA sequencing) in peripheral blood [ Time Frame: 4 hours ]The change in host gene expression (RNA sequencing) over a 4 hour study period.
- Trace amine receptor 1 (TAAR1) signaling metabolite levels in in peripheral blood [ Time Frame: 4 hours ]The change in TAAR1 signaling metabolite levels over a 4 hour study period.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Willing and able to provide written informed consent
- Male or female, age ≥ 18 and ≤ 65 years
- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load.
- Continuous therapy with a Department of Health and Human Services (DHHS) recommended/alternative combination ART for least 24 months (at least 3 agents) at study entry with no regimen changes in the preceding 12 weeks
- Maintenance of undetectable plasma HIV-1 RNA (<40 copies/ml) for at least 12 months. Episodes of single HIV plasma RNA 50-500 copies/ml will not exclude participation if subsequent HIV plasma RNA is <40 copies/ml.
- No plans to modify ART during the study period (146 days, or approximately 5 months)
- Screening CD4+ (cluster of differentiation 4) T-cell count ≥ 350 cells/mm3
- Screening hemoglobin ≥ 12.5 g/dL
- No current or prior history of methamphetamine (MA) use disorder by DSM-5 diagnostic criteria. Participants may have a prior history of taking prescription medications containing amphetamines-type stimulants such as Adderall® or Dexedrine® or Ritalin for the treatment of conditions such as attention deficit hyperactivity disorder as long as the participant has not taken these medications in the last 12 months or plans to take these medications during the entire study period.
- Willingness to use two forms of contraception throughout the study period as well as up to 30 days after the last day of study completion.
- Ability and availability to participate in the full 146 days of the study (approximately 5 month) and maintain the inclusion/exclusion criteria.
Exclusion Criteria:
- History of methamphetamine ("meth") use disorder by DSM-5 diagnostic criteria.
- Evidence of MA use other than due to the administered oral methamphetamine study drug, based on urine, hair, or serum MA measurements collected at baseline and follow-up study visits.
- Current use of prescription medications containing amphetamine-type stimulants (e.g., Adderall®, Dexedrine®, Ritalin, etc.) within the last 1 year.
- Sensitivity or allergy to amphetamine-type stimulants
- Current use of any other "psychoactive" drug within the last 1 year. These include cocaine, ecstasy, lysergic acid diethylamide (LSD), mushrooms, or other recreational drugs - but nicotine or caffeine use is ok.
- Marijuana use in the last 30 days; marijuana may influence the interpretation of the study drug's effect on viral transcription, inflammation, and/or gene expression.
- Current use of opioids (heroin, methadone) or prescription opioid agonists such as hydrocodone (Norco®), buprenorphine/naloxone (Suboxone®), oxycodone (Oxycontin®), hydromorphone (Dilaudid®) within the last 1 year by self-report and/or urine qualitative screening.
- Current use of alcohol use disorder (DSM-5 criteria) within the last 1 year as this might put patient at risk of withdrawal during the study.
- Significant physical or psychiatric illness that might impair the ability to safely complete the study or that might be complicated by the study drugs, including prior seizures (after age 8) or other active neurological disease.
- Clinically significant abnormalities on physical examination or screening laboratory values
- History of serious adverse event or hypersensitivity to MA or corn starch (the latter is used in the placebo).
- Recent use within the last month of the following medications given potential interactions with oral methamphetamine: acebrophylline, iobenguane, isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine, asunaprevir, buproprion, topical cocaine, fluoxetine, iohexol, linezolid, paroxetine, potassium citrate, quinidine, sodium bicarbonate, sodium citrate, sodium lactate, tipranavir, and tromethamine.
- Recent hospitalization in the last 90 days.
- Recent infection in the last 90 days requiring systemic antibiotics.
- Screening hemoglobin below 12.5 g/dL.
- Prior diagnosis or abnormal screening labs consistent with a diagnosis of hyperthyroidism or hypothyroidism.
- Poorly controlled hypertension with systolic blood pressure > 160 on more than one occasion.
- History of glaucoma.
- Significant myocardial disease (current myocarditis or reduced left ventricular ejection fraction below the lower limit of normal) or diagnosed coronary artery disease.
- History of psychotic symptoms (e.g., hallucinations, delusional thinking).
- History of bipolar disorder.
- Significant respiratory disease requiring oxygen.
- A history of hypersensitivity to sympathomimetic amines (e.g., epinephrine, norepinephrine, or dopamine).
- Diabetes or current hypothyroidism.
- Participants of reproductive potential or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test at screening. All participants of childbearing potential must agree to use a double-barrier method of contraception throughout the study period and up to 90 days after the last dose of MA.
- Exposure to any immunomodulatory drug (including maraviroc) in the 16 weeks prior to study.
- Prior or current use of experimental agents used with the intent to perturb the HIV-1 viral reservoir.
- History of seizures, psychosis, abnormal electroencephalogram or brain damage with significant persisting neurological deficit
- Recent vaccination within the last 2 weeks prior to study baseline visit. Routine or standard of care vaccinations (such as influenza, pneumococcal, and meningococcal vaccinations) are allowed but must be administered greater than 14 days prior to baseline study visit.

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): NCT03825536
Contact: Sulggi A Lee, MD PhD | 415-735-5127 | sulggi.lee@ucsf.edu | |
Contact: Paula Lum, MD | 415-476-4082 ext 411 | paula.lum@ucsf.edu |
United States, California | |
San Francisco General Hospital | Recruiting |
San Francisco, California, United States, 94110 | |
Contact: Sulggi A Lee, MD PhD Sulggi.Lee@ucsf.edu |
Principal Investigator: | Sulggi A Lee, MD PhD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT03825536 |
Other Study ID Numbers: |
18-26765 1R61DA047024-01 ( U.S. NIH Grant/Contract ) |
First Posted: | January 31, 2019 Key Record Dates |
Last Update Posted: | March 23, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
HIV methamphetamine viral transcription inflammation |
Acquired Immunodeficiency Syndrome HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Methamphetamine Central Nervous System Stimulants Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors |