HIV InfectionsNCT05916989
Stimulant Use and Methylation in HIV
An observational study of HIV Infections and Methamphetamine-dependence, run by Florida International University at 1 site in United States.
Trial summary
This study will leverage extracted leukocyte DNA specimens from a completed NIH-funded project to examine the efficacy of a behavioral intervention model that reduced stimulant use on DNA methylation over 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections, Methamphetamine-dependence, Methamphetamine Abuse
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2018to 26 Oct 2022
- Phase
- Observational
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Sexual minority men with HIV who use methamphetamine residing in the San Francisco Bay Area.
Who may be able to join
- At least 18 years old
- Documentation of HIV-positive serostatus
- Speak English
- Biological verification of recent methamphetamine use
- Completion of at least three contingency management (CM) visits
- Self reported anal sex with a man in the past 12 months
Who cannot join
- Inability to provide informed consent, evidenced by cognitive impairment
- HIV negative serostatus
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
This study will leverage extracted leukocyte DNA specimens from a completed NIH-funded project to examine the efficacy of a behavioral intervention model that reduced stimulant use on DNA methylation over 6 months.
- Keywords
- HIV, Methamphetamine, Methylation
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Leukocyte DNA Samples | Leukocyte DNA specimens extracted from participants enrolled in a completed NIH funded trial will be examined to determine if prior exposure to different behavioral interventions modifies DNA methylation patterns over 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroimmune Signaling
Decreased methylation of genes for genes relevant to neuroimmune signaling such as beta-2 (β2) adrenergic (i.e., ADRB2), glucocorticoid (i.e., NR3C1 and FKBP5), and oxytocin (i.e., OXTR) receptors as well as brain-derived neurotrophic factor (BDNF) promoters.
Measured: 6 Months
Secondary outcomes (3)
DNA Methylation Pathways
Pathway Analyses examining alterations in methylation patterns relevant to immune and neural function.
Measured: 6 Months
Immune Dysfunction
Soluble makers of monocyte activation such as soluble CD14 (sCD14) and inflammation such as soluble Tumor Necrosis Factor - Alpha Receptors I and II (sTNF-aRI and sTNF-aRII)
Measured: 6 Month
Dysregulated Metabolism of Amino Acid Precursors for Neurotransmitters measured via high-performance liquid chromatography (HPLC)
Using HPLC, higher kynurenine/tryptophan (K/T) ratio indexes catabolism of tryptophan into kynurenine and other downstream catabolites versus serotonin over 6 months. Using HPLC, the phenylalanine/tyrosine ratio reflects decreased metabolism of tyrosine into catecholamines such as dopamine over 6 months.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start30 Sep 2018
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, Northwestern University, University of California, San Francisco, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Adam Carrico, PhD, Florida International University
- Investigators
- Adam W Carrico, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916989
- Sponsor's protocol ID
- 20180865
- Other IDs
- R01DA033854
- Status last verified
- Nov 2023
- First submitted
- 14 Jun 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulant Use and Methylation in HIV
- ClinicalTrials.gov ID
- NCT05916989
- Acronym / sponsor ID
- 20180865
- Keywords
- HIV, Methamphetamine, Methylation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- New York University, Northwestern University, University of California, San Francisco, National Institute on Drug Abuse (NIDA)
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 23 Jun 2023 (actual)
- 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.
This study will leverage extracted leukocyte DNA specimens from a completed NIH-funded project to examine the efficacy of a behavioral intervention model that reduced stimulant use on DNA methylation over 6 months.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leukocyte DNA Samples | – | –Leukocyte DNA specimens extracted from participants enrolled in a completed NIH funded trial will be examined to determine if prior exposure to different behavioral interventions modifies DNA methylation patterns over 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sexual minority men with HIV who use methamphetamine residing in the San Francisco Bay Area.
Key inclusion criteria (6 listed)
- At least 18 years old
- Documentation of HIV-positive serostatus
- Speak English
- Biological verification of recent methamphetamine use
- Completion of at least three contingency management (CM) visits
Key exclusion criteria (2 listed)
- Inability to provide informed consent, evidenced by cognitive impairment
- HIV negative serostatus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuroimmune Signaling
Time frame: 6 Months
Decreased methylation of genes for genes relevant to neuroimmune signaling such as beta-2 (β2) adrenergic (i.e., ADRB2), glucocorticoid (i.e., NR3C1 and FKBP5), and oxytocin (i.e., OXTR) receptors as well as brain-derived neurotrophic factor (BDNF) promoters.
3 secondary outcomes
DNA Methylation Pathways
Time frame: 6 Months
Immune Dysfunction
Time frame: 6 Month
Dysregulated Metabolism of Amino Acid Precursors for Neurotransmitters measured via high-performance liquid chromatography (HPLC)
Time frame: 6 Months
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 2 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Adam W Carrico, PhD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Methamphetamine-dependence, run by Florida International University 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 2 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 2 Nov 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Neuroimmune Signaling (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2023.