Developing cognitive tasks for brain studies in drug users

Cognitive Task Development and Implementation for Functional MRI Studies

This study is testing new brain tasks to see how drug use affects thinking and behavior in people aged 18-65, using brain scans to compare drug users with non-users.

Quick facts

• Study type: Observational
• Enrollment: 750 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT01036685 on ClinicalTrials.gov

What this trial studies

This study focuses on creating and validating cognitive and affective tasks to assess how drug use impacts brain function and behavior. By utilizing functional MRI (fMRI) scans, researchers aim to observe brain activity during these tasks in both drug users and non-users. The study will involve volunteer participants aged 18-65, who will be tested both inside and outside of the MRI scanner to ensure the tasks are effective and reliable. The ultimate goal is to enhance our understanding of the cognitive effects of drug use and inform the development of new treatments for substance abuse.

Who should consider this trial

Good fit: Ideal candidates include healthy volunteers aged 18-65, including both drug users and non-drug users.

Not a fit: Patients who are not within the age range of 18-65 or those who cannot provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved assessments and treatments for individuals struggling with drug abuse and nicotine dependence.

How similar studies have performed: Other studies have shown success in using fMRI to understand brain function related to drug use, making this approach promising but still requiring validation.

Eligibility criteria

* INCLUSION CRITERIA:

Bench Only Phase (no MRI)

Participants will be considered for one of three categories: 379-bench-control, 379-bench-smoker/vaper, 379-bench-user. Vapers will be admitted to experiments involving smoking cues (with cues specific to vaping) because it has been shown that responses to vaping cues are very similar to responses to smoking cues and can be lumped together in analyses.

Participant must meet the following inclusion criteria for the Bench Only Phase:

1. Between the ages of 18-65.
2. All subjects must be able to provide informed consent/assent.
3. Additional criteria for specific populations:

   1. 379-bench-smoker/vaper: regular smoker of tobacco cigarettes or nicotine vaper with a urine cotinine level corresponding to nicotine user status for the specific test being used (typically corresponding to a urine cotinine above about 200 ng/ml) and have been smoking or vaping consistently for at least one year (excluding quit attempts)
   2. 379-bench-user: DSM-V substance use disorder on a substance other than nicotine.

EXCLUSION CRITERIA:

Bench Only Phase (Does not require MRI. Task requires gathering of accurate behavioral data).

1. History of neurologic injury including but not limited to CVA, CNS tumor, or head trauma with persistent sequelae. Assessment tool: pre-screen survey and medical history.

   Rationale: Neurologic injury is likely to impair performance on the range of tasks to be piloted under this protocol.
2. Current use of psychoactive medications likely to affect the performance of the task under consideration, unless required for the psychiatric disorder for which participants in the 379-user and 379-other-psych-diagnosis subcategories are being treated. Assessment tool: pre-screen survey, medical history. Rationale: certain psychoactive medications may alter performance on the range of tasks to be piloted under this protocol.
3. Cognitive impairment. Assessment tool: self report of extended placement in special education classes for learning problems, history of specific learning disability or mental retardation. Rationale: Cognitive impairment is likely to impair performance on the range of tasks to be piloted under this protocol and may impair ability to tolerate the procedures.
4. Current major mood, anxiety or psychotic disorder with symptoms severe enough to impair ability to participate (unless task is being evaluated in a specific clinical population). Assessment tool: self report, medical history. Rationale: Current major mood or psychotic disorders with poorly controlled symptoms may impair performance on the range of tasks to be piloted under this protocol and may impair ability to tolerate the procedures.
5. Non-English speaking. Assessment tool(s): self-report. Rationale: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing study procedures. The inability to effectively communicate safety procedures in a language other than English could compromise the safety of non-English speaking participants.

Where this trial is running

Baltimore, Maryland

• National Institute on Drug Abuse, Biomedical Research Center (BRC) — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Thomas Ross, Ph.D. — National Institute on Drug Abuse (NIDA)
• Study coordinator: NIDA IRP Screening Team

Conditions: Drug Abuse, Nicotine Dependence, Task Development, Natural History, fMRI, Cognition, Affect