Substance Use DisorderNCT02861820
Functional Connectivity Changes During Early Recovery as a Marker for Relapse
An observational study of Substance Use Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
The study purpose is to examine whether there are structural or functional differences in the brains of individuals who use cocaine or amphetamines as opposed to control participants who have never used cocaine or amphetamines. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorder
- What is being tested?
- MRI: Brain Imaging Data Collection
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to 26 Jan 2021
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult individuals with Substance Use Disorder
Who may be able to join
- At least 18 but no more than 45 years old at the time of consent.
- Able to provide written consent and comply with study procedures.
Who cannot join
- Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness for more than 30 minutes, seizures, HIV).
- Any contraindications to MRI scanning (i.e. metal implants, pacemakers, etc.).
- Intellectual developmental disorder as defined in the DSM-V. Participant may have a diagnosis of an Axis I disorder (i.e. anxiety disorders, mood disorders, eating disorders, psychotic disorders), but it must be considered stable.
- Actively suicidal.
- Positive screen for alcohol and/or drugs. Participants who screen positive for drugs and/or alcohol may return at a later date to screen for the study again.
- Evidence for Wernicke-Korsakoff syndrome.
- Healthy Controls may never have had any form of substance use disorder other than caffeine or nicotine. Nicotine use will be recorded but will not be an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
The study purpose is to examine whether there are structural or functional differences in the brains of individuals who use cocaine or amphetamines as opposed to control participants who have never used cocaine or amphetamines. More specifically, it will allow the investigator to see how the brain changes once people get sober and how those changes relate to successful recovery. This study will allow the investigator to examine the interaction between cocaine/amphetamines and impulsivity (meaning to act on impulse rather than thought). Results from this study will inform new biologically-based interventions to compliment existing treatment programs, in the hope of leading the field in a new direction.
- Conditions
- Substance Use Disorder
- Being tested
- MRI: Brain Imaging Data Collection
- Keywords
- fMRI, brain networks, biomarker, relapse, stimulants
- Medical subject headings
- Substance-Related Disorders, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI: Brain Imaging Data CollectionDevice
This study has no intervention, it is observational. The investigator will collect brain imaging data and behavioral assessments.
| Study group | Role | What they receive |
|---|---|---|
| Substance Use Disorder (SUD) | Participants in the SUD group will:
* Complete a diagnostic screening interview at baseline.
* Complete questionnaires and computer tasks at baseline, 1 month and 2 month time points.
* Complete MRI brain imaging data collection at the baseline, 1 month and 2 month time points.
* Complete 9 follow-up phone calls to assess for relapse. Receives: Device: MRI: Brain Imaging Data Collection | |
| Healthy Control (HC) | Participants in the HC group will:
* Complete a diagnostic screening interview at baseline.
* Complete questionnaires and computer tasks at baseline and 2 month time points.
* Complete MRI brain imaging data collection at the baseline and 2 month time points. Receives: Device: MRI: Brain Imaging Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain connectivity
3T MRI scan
Measured: Change from Baseline, to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start1 Jul 2015
- Primary completion4 Mar 2020
- Study completion26 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kelvin O Lim, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861820
- Sponsor's protocol ID
- PSYCH-2016-24183
- Other IDs
- 1R01DA038984-01A1
- Status last verified
- Jan 2022
- First submitted
- 1 Aug 2016
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: As requested
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Connectivity Changes During Early Recovery as a Marker for Relapse
- ClinicalTrials.gov ID
- NCT02861820
- Acronym / sponsor ID
- PSYCH-2016-24183
- Conditions
- Substance Use Disorder
- Keywords
- fMRI, brain networks, biomarker, relapse, stimulants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 10 Aug 2016 (estimated)
- 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 study purpose is to examine whether there are structural or functional differences in the brains of individuals who use cocaine or amphetamines as opposed to control participants who have never used cocaine or amphetamines. More specifically, it will allow the investigator to see how the brain changes once people get sober and how those changes relate to successful recovery. This study will allow the investigator to examine the interaction between cocaine/amphetamines and impulsivity (meaning to act on impulse rather than thought). Results from this study will inform new biologically-based interventions to compliment existing treatment programs, in the hope of leading the field in a new direction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Substance Use Disorder (SUD) | – | Device: MRI: Brain Imaging Data CollectionParticipants in the SUD group will: * Complete a diagnostic screening interview at baseline. * Complete questionnaires and computer tasks at baseline, 1 month and 2 month time points. * Complete MRI brain imaging data collection at the baseline, 1 month and 2 month time points. * Complete 9 follow-up phone calls to assess for relapse. |
| Healthy Control (HC) | – | Device: MRI: Brain Imaging Data CollectionParticipants in the HC group will: * Complete a diagnostic screening interview at baseline. * Complete questionnaires and computer tasks at baseline and 2 month time points. * Complete MRI brain imaging data collection at the baseline and 2 month time points. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult individuals with Substance Use Disorder
Key inclusion criteria (2 listed)
- At least 18 but no more than 45 years old at the time of consent.
- Able to provide written consent and comply with study procedures.
Key exclusion criteria (7 listed)
- Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness for more than 30 minutes, seizures, HIV).
- Any contraindications to MRI scanning (i.e. metal implants, pacemakers, etc.).
- Intellectual developmental disorder as defined in the DSM-V. Participant may have a diagnosis of an Axis I disorder (i.e. anxiety disorders, mood disorders, eating disorders, psychotic disorders), but it must be considered stable.
- Actively suicidal.
- Positive screen for alcohol and/or drugs. Participants who screen positive for drugs and/or alcohol may return at a later date to screen for the study again.
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 |
|---|---|---|
| MRI: Brain Imaging Data CollectionThis study has no intervention, it is observational. The investigator will collect brain imaging data and behavioral assessments. | Device | Healthy Control (HC), Substance Use Disorder (SUD) |
Primary outcome
Brain connectivity
Time frame: Change from Baseline, to 2 months
3T MRI scan
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 21 Jan 2022.
- Individual participant dataSharing planned: Yes. As requested
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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.
Kelvin O Lim, MD principal investigator
University of Minnesota
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 Substance Use Disorder, run by University of Minnesota 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 2 inclusion and 7 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 21 Jan 2022. 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?
Brain connectivity (time frame: Change from Baseline, to 2 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 21 Jan 2022; AzTrials last refreshed its copy on 29 Oct 2026.