Substance UseSIGNNCT07094061
Neurobehavioral Signatures of Sign- and Goal-Tracking in Emerging Adults: Translation of a Preclinical Model
A study testing fMRI, Questionnaires and surveys and Behavioral tasks and eye tracking in people with Substance Use and Healthy, run by University of Michigan at 2 sites in United States.
Trial summary
This study seeks to understand individual differences in personality, brain function, and behavior. Study hypothesis: A stronger sign-tracking bias will be associated with a bottom-up processing style characterized by less adaptive attentional- and impulse-control as well as hyperactive reward processing, whereas a… Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Healthy
- What is being tested?
- fMRI, Questionnaires and surveys and Behavioral tasks and eye tracking
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Oct 2025to Aug 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 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-22 years old at baseline
- Right-handed
- Medically/physically able to give informed consent
- English-speaking
- Substance use is free to vary, but for participants with a history of substance use, ≥ 1 use of cannabis (including less than a full dose)
Who cannot join
- Acute or chronic medical or neurological illness (e.g., diabetes, epilepsy, migraine)
- History of psychosis in self or first-degree relative
- Current treatment for substance use disorder
- Current or past 6-month treatment with centrally acting medications (not including attention deficit hyperactivity disorder (ADHD) medication)
- Intelligence quotient (IQ) < 70
- Lifetime history of head trauma with loss of consciousness > 5 minutes
Show all 9Show fewer
- Reliance on glasses to be able to read small text at a distance of approximately 30 inches
- Colorblindness
- MRI contraindication (e.g., pregnancy, metal implants, claustrophobia) per protocol
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rachel Upjohn Building
Ann Arbor, Michigan, 48109
Loree Brennan O'Jack, CPA, MHSA, 734-232-0227, loree@med.umich.edu
Lora M Cope, PhD
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Paul Holdefer, MPH, 734-998-9239, holdefer@umich.edu
Lora Cope, PhD
About this study
This study seeks to understand individual differences in personality, brain function, and behavior.
Study hypothesis:
- A stronger sign-tracking bias will be associated with a bottom-up processing style characterized by less adaptive attentional- and impulse-control as well as hyperactive reward processing, whereas a stronger goal-tracking bias will be associated with a top-down processing style characterized by strong attentional- and impulse-control as well as normative reward processing.
- Conditions
- Substance Use, Healthy
- Being tested
- fMRI, Questionnaires and surveys, Behavioral tasks and eye tracking
- Keywords
- Functional magnetic resonance imaging (fMRI), Questionnaires, Interviews, Behavioral tasks
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDevice
Participants will have an MRI to scan participants brains and will wear skin conductance electrodes on the hand and fill out questionnaires. Scanning will take approximately 90 minutes. While lying in the scanner, participants will be asked to perform some tasks. The tasks will be presented to participants visually on a screen in the scanner and eye movements will also be tracked during some of these tasks. Participants will respond to stimuli with button presses that are recorded by computer.
Questionnaires and surveysBehavioural
Participants will have multiple visits during this study and fill out various surveys at these visits.
Behavioral tasks and eye trackingBehavioural
Participants will perform behavioral tasks while having eye-tracking hardware monitor participants eye movements. A video camera will be used to record eye movements during the behavioral tasks.
| Study group | Role | What they receive |
|---|---|---|
| Assessment group | Experimental | Not described Receives: Device: fMRI; Behavioral: Questionnaires and surveys; Behavioral: Behavioral tasks and eye tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Pavlovian conditioned approach (PavCA) bias score (out-of-scanner) and composite cannabis use score
PavCA bias score based on eye gaze during the Pavlovian conditioned approach task will be correlated with a cannabis use composite score based on the Substance Use History and Timeline Follow-Back.
Measured: Baseline
Secondary outcomes (1)
Correlation between PavCA bias score (out-of-scanner) and activation from the Cannabis Cue Reactivity Task (P-CAN)
PavCA bias score based on eye gaze during the Pavlovian conditioned approach task will be correlated with the first principal component of average parameter estimates from the following regions extracted for the cannabis vs. neutral contrast: ventral striatum, anterior cingulate, posterior cingulate, insula, amygdala, orbitofrontal cortex, inferior occipital cortex, and inferior parietal cortex
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start3 Oct 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a longitudinal, repeated-measures, naturalistic study that will take place at the University of Michigan.
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lora Cope, University of Michigan
- Investigators
- Lora Cope, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094061
- Sponsor's protocol ID
- HUM00269332
- Other IDs
- R01DA058010
- Acronym
- SIGN
- Status last verified
- Jun 2026
- First submitted
- 22 Jul 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The scientific data collected will be preserved to enable sharing via Inter-university Consortium for Political and Social Research (ICPSR)/National Addiction \& HIV Data Archive Program (NAHDAP). The demographic, clinical, and psychometric raw and composite data will both be preserved and shared, and respondent identifiers will be removed and maintained in a secure file for future contact purposes. Where applicable, sensitive data will be managed using ICPSR/NAHDAP's restricted data dissemination practices to ensure the data are kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Signatures of Sign- and Goal-Tracking in Emerging Adults: Translation of a Preclinical Model
- ClinicalTrials.gov ID
- NCT07094061
- Acronym / sponsor ID
- SIGN / HUM00269332
- Conditions
- Substance Use, Healthy
- Keywords
- Functional magnetic resonance imaging (fMRI), Questionnaires, Interviews, Behavioral tasks
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 30 Jul 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.
This study seeks to understand individual differences in personality, brain function, and behavior.
Study hypothesis:
- A stronger sign-tracking bias will be associated with a bottom-up processing style characterized by less adaptive attentional- and impulse-control as well as hyperactive reward processing, whereas a stronger goal-tracking bias will be associated with a top-down processing style characterized by strong attentional- and impulse-control as well as normative reward processing.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a longitudinal, repeated-measures, naturalistic study that will take place at the University of Michigan.
| Arm | Type | Receives |
|---|---|---|
| Assessment group | Experimental | Device: fMRI, Behavioral: Questionnaires and surveys, Behavioral: Behavioral tasks and eye tracking |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-22 years old at baseline
- Right-handed
- Medically/physically able to give informed consent
- English-speaking
- Substance use is free to vary, but for participants with a history of substance use, ≥ 1 use of cannabis (including less than a full dose)
Key exclusion criteria (9 listed)
- Acute or chronic medical or neurological illness (e.g., diabetes, epilepsy, migraine)
- History of psychosis in self or first-degree relative
- Current treatment for substance use disorder
- Current or past 6-month treatment with centrally acting medications (not including attention deficit hyperactivity disorder (ADHD) medication)
- Intelligence quotient (IQ) < 70
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 |
|---|---|---|
| fMRIParticipants will have an MRI to scan participants brains and will wear skin conductance electrodes on the hand and fill out questionnaires. Scanning will take approximately 90 minutes. While lying in the scanner, participants will be asked to perform some tasks. The tasks will be presented to participants visually on a screen in the scanner and eye movements will also be tracked during some of these tasks. Participants will respond to stimuli with button presses that are recorded by computer. | Device | Assessment group |
| Questionnaires and surveysParticipants will have multiple visits during this study and fill out various surveys at these visits. | Behavioural | Assessment group |
| Behavioral tasks and eye trackingParticipants will perform behavioral tasks while having eye-tracking hardware monitor participants eye movements. A video camera will be used to record eye movements during the behavioral tasks. | Behavioural | Assessment group |
Primary outcome
Correlation between Pavlovian conditioned approach (PavCA) bias score (out-of-scanner) and composite cannabis use score
Time frame: Baseline
PavCA bias score based on eye gaze during the Pavlovian conditioned approach task will be correlated with a cannabis use composite score based on the Substance Use History and Timeline Follow-Back.
1 secondary outcome
Correlation between PavCA bias score (out-of-scanner) and activation from the Cannabis Cue Reactivity Task (P-CAN)
Time frame: Baseline
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 10 Jun 2026.
- Individual participant dataSharing planned: Yes. The scientific data collected will be preserved to enable sharing via Inter-university Consortium for Political and Social Research (ICPSR)/National Addiction \& HIV Data Archive Program (NAHDAP). The demographic, clinical, and psychometric raw and composite data will both be preserved and shared, and respondent identifiers will be removed and maintained in a secure file for future contact purposes. Where applicable, sensitive data will be managed using ICPSR/NAHDAP's restricted data dissemination practices to ensure the data are kept confidential.
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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.
Lora Cope, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI, Questionnaires and surveys and Behavioral tasks and eye tracking in people with Substance Use and Healthy, run by University of Michigan at 2 sites 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 9 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Paul Holdefer, MPH (734-998-9239, holdefer@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Pavlovian conditioned approach (PavCA) bias score (out-of-scanner) and composite cannabis use score (time frame: Baseline). 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 10 Jun 2026.