Stimulant UseNCT06814275
Project neuroARTEMIS
A study testing ARTEMIS and Contingency management for Antiretroviral (ARV) adherence in people with Stimulant Use and Human Immunodeficiency Virus (HIV), run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research is to understand how chronic stress affects the way our brain and immune systems function, and in turn how this affects the way people feel, think, and behave. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Stimulant Use, Human Immunodeficiency Virus (HIV), Depression
- What is being tested?
- ARTEMIS and Contingency management for Antiretroviral (ARV) adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-59 years old
- Weekly use of stimulants reported in the past month or a score of 4 or more on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
- Confirmed HIV diagnosis
- Current receipt of daily oral antiretroviral therapy (ART) medication
- English fluency/literacy
Who cannot join
- Acute brain infection (e.g., neurosyphilis, toxoplasmosis)
- Acutely symptomatic bipolar I or psychotic disorder
- Prescription for immunomodulatory medications or other immunotherapy
- Any MRI contraindications
- If applicable, on antidepressant medication regimen for at least 2 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101
Christina S Meade, PhD, 336-716-0695, cmeade@wakehealth.edu
Sheri L Towe, PhD, 336-716-4331, stowe@wakehealth.edu
About this study
Official title: Project ARTEMIS: A Mechanistic Clinical Trial of Neuroimmune Pathways.
The purpose of this research is to understand how chronic stress affects the way our brain and immune systems function, and in turn how this affects the way people feel, think, and behave. By learning more about how these processes work, the hope is to be able to develop better treatments to help with problems like depression and substance use. This study is intended for individuals that are HIV positive, currently taking prescription antiretroviral medications, and use stimulants. Through this intervention, the aim is to determine if this positive affect intervention can lead to reductions in stimulant use and depressed mood.
Read the detailed description
Participants who meet initial eligibility criteria will complete a baseline assessment that includes psychosocial and behavioral measures, biospecimen collection, and an MRI brain scan. Participants will then be randomized to either: 1) ARTEMIS; or 2) a waitlist control (WLC) condition. ARTEMIS participants will receive 5 sessions delivered individually over Zoom across 3 months. All participants (including WLC) will receive contingency management (CM) for antiretroviral therapy (ART) adherence to support sustained viral suppression over the active phase of the trial. During the intent-to-treat period, assessments at 3- and 6-month follow-ups will characterize changes in neural activity (assessed via fMRI) and conserved transcriptional response to adversity (CTRA) leukocyte signaling (assessed via RNA sequencing) as plausible mediators of behavioral outcomes following ARTEMIS. WLC participants will be offered the ARTEMIS intervention after a 6-month delay.
- Being tested
- ARTEMIS, Contingency management for Antiretroviral (ARV) adherence
- Keywords
- HIV, Stimulant use, substance abuse, chronic stress
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTEMISBehavioural
The ARTEMIS intervention includes 5 sessions delivered individually over Zoom across 3 months. The intervention teaches 9 positive affect skills: noting and capitalizing on positive events, gratitude journaling, formal and informal mindfulness, positive reappraisal and problem solving coping skills training, focusing on personal strengths, setting achievable goals, and small acts of kindness. Each session consists of a didactic portion with in vivo skills practice, and participants are asked to complete daily home practice of the skills between sessions.
Contingency management for Antiretroviral (ARV) adherenceBehavioural
All participants will received the contingency management (CM) intervention to support ARV adherence. They will use the Spotlight by Scene Health platform, a HIPAA-compliant mHealth application for directly observed therapy, to upload videos of ART adherence. The app records and uploads time-stamped videos of medication doses, which staff verify asynchronously. Participants will be paid for each verified dose and receive a weekly bonus if they complete 6 doses.
| Study group | Role | What they receive |
|---|---|---|
| ARTEMIS | Active comparator | Participants in this arm will receive the ARTEMIS intervention immediately following randomization. Receives: Behavioral: ARTEMIS; Behavioral: Contingency management for Antiretroviral (ARV) adherence |
| Waitlist Control (WLC) | Other | Participants in the WLC arm will be offered the ARTEMIS intervention after the final (6-month) follow-up. Receives: Behavioral: Contingency management for Antiretroviral (ARV) adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural Functional Connectivity
Functional connectivity (FC) will be derived from the the resting-state functional MRI data. Using a theory-driven, seed-based approach, the 4D time series [average blood oxygenation level dependent (BOLD) signal across voxels] will be extracted from a priori seeds in the reward network (i.e., nucleus accumbens, subgenual anterior cingulate cortex, medial orbitofrontal cortex). Normalized Z-scores will be calculated for FC between regions of interest. These analyses will control for baseline FC.
Measured: Month 3
Neural Activation
The Monetary Incentive Delay Task will be used to probe neural activation to reward processing, using an event-level design. Blood oxygenation level dependent (BOLD) activation will be modeled as a canonical hemodynamic response function specified at stimulus onset. Event epochs that are time locked to the onset of each trial will be extracted from the overall time series. Random-effects general linear model will be used to calculate statistical parametric maps reflecting the probability that a voxel is activated as a function of the experimental task. The primary analysis will focus on nucleus accumbens and ventromedial prefrontal cortex activity as regions of interest (ROI). Mean beta values will be averaged across all voxels in each ROI. These analyses will control for baseline activation levels.
Measured: Month 3
Secondary outcomes (4)
Change in Frequency of Stimulant Use
Utilizing a Timeline Follow-back, days of stimulant use in past 30 will be assessed. Stimulants will include methamphetamine, other amphetamines, cocaine, and other stimulants. Change in use from baseline will be examined.
Measured: 3 and 6 month follow-ups
Depression Scores
Depression symptom severity, measured via (CES) Center for Epidemiologic Studies Depression Scale. This assessment is a 20 item assessment with each item being assigned a value of 0-3. Higher scores are indicative of depression. The total score is calculated by calculating the sum of 20 items. Scores range from 0-60, with higher scores meaning greater depressive symptoms. We will examine change from baseline.
Measured: 3 and 6 month follow-ups
CTRA Leukocyte Signaling
RNA sequencing (RNAseq) of peripheral blood mononuclear cells (PBMCs) will be conducted for analysis of differential gene expression, detection of low expressed genes, allele specific expression analysis, and splice variants. Gene expression values will be log2-transformed and pre-specified sets of inflammatory and Type I interferon genes will be combined into a single-number CTRA indicator (53-gene contrast score).
Measured: Baseline, Month 3, Month 6
Change in Peripheral Inflammation
Plasma samples will undergo multiplexed analysis for key inflammatory mediators: CRP, TNF-a, IFN-g, IL-1b, IL-6, CXCL10, and CCL2. Single-enzyme-linked immunoabsorbent assays (ELISAs) will be performed for sCD14 and sCD163. We will examine changes in concentration from baseline.
Measured: 3 and 6 month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start29 Apr 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stimulant UseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will utilize two treatment arms in which participants are randomized using a 2:1 allocation. Arm A will receive the ARTEMIS intervention immediately following their baseline visit. Arm B will be considered a wait-list control, being offered the ARTEMIS intervention after a 6-month delay.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Florida International University, National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Christina S Meade, PhD, Principal investigator, Wake Forest University Health SciencesAdam W Carrico, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814275
- Sponsor's protocol ID
- IRB00117907
- Other IDs
- 1R01DA061952-01
- Status last verified
- Aug 2026
- First submitted
- 3 Feb 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual-level phenotypic, clinical, genomic, and neuroimaging data for all research subjects will be preserved and deposited in designated NIH-supported repositories for sharing broadly with the scientific community (described below). While identifiers will be collected, all data will be de-identified prior to deposit into any repository. Shared data will include raw and processed files for genomic and neuroimaging data. Recruitment progress and final results will be documented at ClinicalTrials.gov. The sources of data include clinical interviewing, computerized questionnaires, neuropsychological testing, biological sampling (blood and urine), MRI neuroimaging, and medical record review. The final dataset from this project will also include data on demographic factors (including biological variables) and clinical variables such as HIV disease characteristics.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project ARTEMIS: A Mechanistic Clinical Trial of Neuroimmune Pathways.
- ClinicalTrials.gov ID
- NCT06814275
- Acronym / sponsor ID
- IRB00117907
- Keywords
- HIV, Stimulant use, substance abuse, chronic stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Florida International University, National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Feb 2025 (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.
The purpose of this research is to understand how chronic stress affects the way our brain and immune systems function, and in turn how this affects the way people feel, think, and behave. By learning more about how these processes work, the hope is to be able to develop better treatments to help with problems like depression and substance use. This study is intended for individuals that are HIV positive, currently taking prescription antiretroviral medications, and use stimulants. Through this intervention, the aim is to determine if this positive affect intervention can lead to reductions in stimulant use and depressed mood.
Detailed description
Participants who meet initial eligibility criteria will complete a baseline assessment that includes psychosocial and behavioral measures, biospecimen collection, and an MRI brain scan. Participants will then be randomized to either: 1) ARTEMIS; or 2) a waitlist control (WLC) condition. ARTEMIS participants will receive 5 sessions delivered individually over Zoom across 3 months. All participants (including WLC) will receive contingency management (CM) for antiretroviral therapy (ART) adherence to support sustained viral suppression over the active phase of the trial. During the intent-to-treat period, assessments at 3- and 6-month follow-ups will characterize changes in neural activity (assessed via fMRI) and conserved transcriptional response to adversity (CTRA) leukocyte signaling (assessed via RNA sequencing) as plausible mediators of behavioral outcomes following ARTEMIS. WLC participants will be offered the ARTEMIS intervention after a 6-month delay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will utilize two treatment arms in which participants are randomized using a 2:1 allocation. Arm A will receive the ARTEMIS intervention immediately following their baseline visit. Arm B will be considered a wait-list control, being offered the ARTEMIS intervention after a 6-month delay.
| Arm | Type | Receives |
|---|---|---|
| ARTEMIS | Active comparator | Behavioral: ARTEMIS, Behavioral: Contingency management for Antiretroviral (ARV) adherenceParticipants in this arm will receive the ARTEMIS intervention immediately following randomization. |
| Waitlist Control (WLC) | Other | Behavioral: Contingency management for Antiretroviral (ARV) adherenceParticipants in the WLC arm will be offered the ARTEMIS intervention after the final (6-month) follow-up. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-59 years old
- Weekly use of stimulants reported in the past month or a score of 4 or more on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
- Confirmed HIV diagnosis
- Current receipt of daily oral antiretroviral therapy (ART) medication
- English fluency/literacy
Key exclusion criteria (5 listed)
- Acute brain infection (e.g., neurosyphilis, toxoplasmosis)
- Acutely symptomatic bipolar I or psychotic disorder
- Prescription for immunomodulatory medications or other immunotherapy
- Any MRI contraindications
- If applicable, on antidepressant medication regimen for at least 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTEMISThe ARTEMIS intervention includes 5 sessions delivered individually over Zoom across 3 months. The intervention teaches 9 positive affect skills: noting and capitalizing on positive events, gratitude journaling, formal and informal mindfulness, positive reappraisal and problem solving coping skills training, focusing on personal strengths, setting achievable goals, and small acts of kindness. Each session consists of a didactic portion with in vivo skills practice, and participants are asked to complete daily home practice of the skills between sessions. | Behavioural | ARTEMIS |
| Contingency management for Antiretroviral (ARV) adherenceAll participants will received the contingency management (CM) intervention to support ARV adherence. They will use the Spotlight by Scene Health platform, a HIPAA-compliant mHealth application for directly observed therapy, to upload videos of ART adherence. The app records and uploads time-stamped videos of medication doses, which staff verify asynchronously. Participants will be paid for each verified dose and receive a weekly bonus if they complete 6 doses. | Behavioural | ARTEMIS, Waitlist Control (WLC) |
Primary outcome
Neural Functional Connectivity
Time frame: Month 3
Functional connectivity (FC) will be derived from the the resting-state functional MRI data. Using a theory-driven, seed-based approach, the 4D time series [average blood oxygenation level dependent (BOLD) signal across voxels] will be extracted from a priori seeds in the reward network (i.e., nucleus accumbens, subgenual anterior cingulate cortex, medial orbitofrontal cortex). Normalized Z-scores will be calculated for FC between regions of interest. These analyses will control for baseline FC.
Neural Activation
Time frame: Month 3
The Monetary Incentive Delay Task will be used to probe neural activation to reward processing, using an event-level design. Blood oxygenation level dependent (BOLD) activation will be modeled as a canonical hemodynamic response function specified at stimulus onset. Event epochs that are time locked to the onset of each trial will be extracted from the overall time series. Random-effects general linear model will be used to calculate statistical parametric maps reflecting the probability that a voxel is activated as a function of the experimental task. The primary analysis will focus on nucleus accumbens and ventromedial prefrontal cortex activity as regions of interest (ROI). Mean beta values will be averaged across all voxels in each ROI. These analyses will control for baseline activation levels.
4 secondary outcomes
Change in Frequency of Stimulant Use
Time frame: 3 and 6 month follow-ups
Depression Scores
Time frame: 3 and 6 month follow-ups
CTRA Leukocyte Signaling
Time frame: Baseline, Month 3, Month 6
Change in Peripheral Inflammation
Time frame: 3 and 6 month follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. All individual-level phenotypic, clinical, genomic, and neuroimaging data for all research subjects will be preserved and deposited in designated NIH-supported repositories for sharing broadly with the scientific community (described below). While identifiers will be collected, all data will be de-identified prior to deposit into any repository. Shared data will include raw and processed files for genomic and neuroimaging data. Recruitment progress and final results will be documented at ClinicalTrials.gov. The sources of data include clinical interviewing, computerized questionnaires, neuropsychological testing, biological sampling (blood and urine), MRI neuroimaging, and medical record review. The final dataset from this project will also include data on demographic factors (including biological variables) and clinical variables such as HIV disease characteristics.
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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.
Christina S Meade, PhD principal investigator
Wake Forest University Health Sciences
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?
A study testing ARTEMIS and Contingency management for Antiretroviral (ARV) adherence in people with Stimulant Use and Human Immunodeficiency Virus (HIV), run by Wake Forest University Health Sciences 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina S Meade, PhD (336-716-0695, cmeade@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural Functional Connectivity (time frame: Month 3). The study lists 2 primary outcomes in all. 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 3 Sep 2026.