Recruiting

Cognition in SUDs

Sponsor:

Virginia Commonwealth University

Code:

NCT07178158

Conditions

Substance Use Disorders

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Installing the Metacognium software app

Continue treatment as usual

Study Details

Brief summary:

Addiction is a brain disorder characterized by a broad range of both apparent and subtle cognitive impairments in attention, memory, executive functions, and decision-making. These cognitive problems are clinically significant and may contribute to poor treatment outcomes in people with Substance Use Disorders (SUDs), such as a high risk of dropout, low treatment compliance, and shorter periods of abstinence. Studies on cognitive function in SUDs reveal that chronic use of drugs and alcohol can also negatively affect another crucial component of cognition: awareness, or metacognition. Metacognition is defined as an individual's ability to perceive and understand their cognitive functions and use this understanding to regulate them. One of the key consequences of metacognitive impairments is the lack of insight in people with SUDs, which adversely affects treatment outcomes. Substance users with poor metacognition are more reluctant to initiate or continue treatment and are more likely to deny their cognitive problems. Therefore, improving metacognition may remove or reduce motivational barriers to invest time and effort in the recovery process in general, and in the brain recovery process specifically. Despite the importance of neurocognition and metacognition in the recovery process for substance users, there is a dearth of interventions designed to target these functions.

Conditions

Substance Use Disorders

Study ID

NCT07178158

Start date

Jul 23, 2026

Status verified date

Aug, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • current DSM-5 opioid and/or stimulant use disorder
  • currently on medication treatment for SUD
  • owning a smartphone with sufficient functionality to download and utilize the NIPA app.

Exclusion Criteria:

  • current psychosis, mania, or suicidal/homicidal ideation
  • non-English speaking

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: The intervention condition

The intervention condition consists of TAU plus four \~20-minute long NIPA sessions, administered a week apart (NIPA+TAU). Participants in both intervention and control conditions would undergo two survey assessments on REDCap, one at baseline and one at the end of the intervention for the NIPA+TAU condition or at the end of week 4 for the TAU condition.

placebo comparator: Control condition

The control condition consists of treatment as usual (TAU) consisting of medication treatment (buprenorphine) and group or individual behavior therapy. Participants in both intervention and control conditions would undergo two survey assessments on REDCap, one at baseline and one at the end of the intervention for the NIPA+TAU condition or at the end of week 4 for the TAU condition.

Interventions

Installing the Metacognium software app

Participants in the NIPA+TAU group will be sent two, URL's (one for iOS and one for Android) for installing the Metacognium software app, which hosts the four NIPA sessions. Participants will be provided with unique ID for registering and using the program on the Metacognium app. The NIPA sessions will be locked until participants have completed their baseline assessment. Once participants complete each NIPA session, they will receive an email and/or text notifying them that the next session is unlocked and that they can proceed to complete it.

Continue treatment as usual

Continue your treatment schedule as usual with the for 4 weeks.

Primary outcome measure

  • Feasibility of recruiting for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention [ Time Frame: Baseline through 4 week intervention ]
  • Retention/adherence rate for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) Intervention [ Time Frame: Baseline through 4 week intervention ]
  • Completion rate for the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention [ Time Frame: Baseline through 4 week intervention ]
  • Measure acceptability of the Neuroscience-Informed Psychoeducation for Addiction (NIPA) intervention [ Time Frame: Baseline through 4 week intervention ]

Central Contacts and Locations

Central contacts

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

kayla McLean

804-828-8402

Principal Investigator:

Jasmin Vassileva

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • tES/TMA: Transcranial electrical stimulation
  • CT: Cognitive Training
  • DASES: Drug Abstinence Self-Efficacy Scale

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-08-07.