Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03373240
Other study ID # 2000021496
Secondary ID 2P50DA009241-21
Status Completed
Phase N/A
First received
Last updated
Start date January 22, 2018
Est. completion date October 17, 2019

Study information

Verified date December 2020
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We are proposing a small randomized clinical trial in which 100 substance users will complete the existing Psychotherapy Development Center (PDC) pretreatment assessment battery as well as a novel battery of assays to evaluate cognitive-affective functioning. After completing pretreatment assessments, participants will be randomized to either a (1) cognitive remediation program (training tasks) specifically designed to address cognitive-affective dysregulation or (2) control tasks (verbal fluency tasks). Tasks will be completed twice per week for 4 weeks, after which assessment batteries will be repeated. Finally, we will evaluate real-world behavior and the durability of the training via a one-month follow-up, which will include assessment of substance use as well as the cognitive-affective battery.


Description:

Participants will be 100 individuals (aged 18 to 50) enrolled in outpatient (non- methadone/buprenorphine) treatment for any substance use disorder (other than PCP) at the Substance Abuse Treatment Unit in New Haven. As the goal of this project is to develop interventions that address self-regulation across multiple disorders, we will recruit individuals who have a range of substance use disorders and levels of severity. Our primary Specific Aim will be to evaluate the efficacy of the cognitive-remediation program relative to the control condition control on the indicators of cognitive-affective functioning and substance use, testing the hypothesis that individuals randomized to the cognitive remediation program will demonstrate improved functioning on the cognitive-affective battery as well as reduced real-world substance abuse. We will also explore potential moderators of response to the training, including baseline measures of cognitive-affective function.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date October 17, 2019
Est. primary completion date October 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Meet current DSM-5 criteria for an alcohol, stimulant, cannabis, or opioid use disorder. - Are sufficiently stable for 4 weeks of outpatient treatment. - Are willing to provide locator information. - Are fluent in English and have a 4th grader or higher reading level Exclusion Criteria: - Meet DSM-5 criteria for a bipolar or schizophrenic disorder. - Who have a legal case pending such that incarceration during the 4-week protocol is likely. - Are physically dependent on alcohol, opioids or benzodiazepines or who report recent PCP use. - Have a baseline Shipley estimated IQ less than 70 - Have 3 or more head injuries with loss of consciousness for over 30 minutes or lasting effects - Have a history of chronic illness or neurological disorders (e.g., epilepsy or stroke) that would complicate evaluation of effects of cognitive training

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
TAU plus Cognitive Remediation Program
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
TAU plus Control Tasks
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.

Locations

Country Name City State
United States Substance Abuse Treatment Center (SATU) New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Stop Signal Reaction Time Improved functioning on cognitive-affective battery: Examining Stop Signal reaction time changed across the 4-week training period. A change score was calculated. A negative number indicates better inhibition over time. Training visit 1 through 4 weeks of training
Primary Change From Pre-Post in Substance Use The cube root of the number of days the participant endorsed using their primary substance. The number of days was submitted to a cube root transformation given skewness and a change score was calculated (post minus pre). A negative number indicated decreased substance use over time. 4 weeks before First Training Session through the 4-week training period
Primary Change in Pre-Post Cognitive Affective Battery- Negative Urgency Subscale (Part of the Urgency, Premeditation (Lack of), Perseverance (Lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale) Negative urgency (NU) subscale. The scale score range is 11-44. Higher values indicate stronger agreement with this pathway toward impulsivity. A change score was calculated. A negative number indicates less agreement with negative urgency. from the week prior to training to the week after training
Primary Change in Experimental Performance-Change in Percentage of Risky Choices Under Risk Condition of the Lottery Task The percent of risky choices per session. This would indicate that the participant selected the lottery option that reflected a riskier bet.
A change score was calculated. A negative number indicates improved decision-making (selecting fewer risky options).
Training visit 1 through 4 weeks of training
Primary Change in Experimental Performance- Change in Percentage of Ambiguous Choices Under 24% Ambiguity in Lottery Task Percent of choices the participant made that reflected selecting the ambiguous option.
A change score was calculated. A negative number reflects improved decision-making (selecting more safe options).
Training visit 1 through 4 weeks of training
Primary Change in Experimental Performance- Paced Auditory Serial Addition Test (PASAT) Estimated change in percentage of trial attempts on round 3 of the PASAT. A positive number reflects more trial attempts in the third round of PASAT. from the week prior to training (pre) to the week after training (post)
Primary Change in Pre-Post Cognitive Affective Battery: Digit Backwards Score on digit backwards. Fourteen strings of varying lengths (2 to 7 digits) are presented. A participant receives a point for each string they correctly repeat backwards. Range 0-14 points. Change score was calculated-positive values indicate improved working memory over time. from the week prior to training (pre) to the week after training (post)
Primary Change in Pre-Post Cognitive Affective Battery: Breath Holding Negative emotionality-distress tolerance as measured by the difference between when the participant says they are uncomfortable and when they let go of holding their breath. Measured in seconds (this was natural log-transformed due to skewness for analyses). Positive change indicates improved distress tolerance over time. from the week prior to training (pre) to the week after training (post)
Primary Change in Pre-Post Cognitive Affective Battery: Perceived Stress Scale Negative emotionality-perceived stress. The total score ranges from 0-4. Higher scores indicate a higher level of perceived stress. A change score was calculated. Negative change indicates an improvement (reduction in perceived stress) over time. from the week prior to training (pre) to the week after training (post)
Primary Change in Pre-Post Cognitive Affective Battery: Delay Discounting Incentive salience- delay discounting. Five-Trial Adjusting-Delay Discounting Task (Koffarnus & Bickel, 2014) is a 5-item behavioral assessment used to estimate the extent to which individuals prefer smaller immediate rewards over larger delayed rewards. A discount rate (ln (k)) is calculated for each time the measure is used. Discount rates for the 5- trial delay task were calculated by taking the inverse of the obtained Effective Delay 50 value, which is equivalent to the value of k, when fitted to this singular point. Ln(k) is the natural log of the discount rate. A change score was calculated. Negative change indicates improved decision-making from the week prior to training (pre) to the week after training (post)
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Completed NCT02224508 - Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks N/A
Completed NCT01413529 - HEART to HAART: Smartphone Intervention to Improve HAART Adherence for Drug Users Phase 2
Completed NCT01141920 - Comparison of Two Counseling Induction Strategies N/A
Completed NCT00237822 - Increasing Treatment Adherence in Co-Occurring Psychiatric and Drug Use Disorders Phase 2
Completed NCT03678051 - CBT4CBT for Women in Residential Treatment for Substance Use Disorders N/A
Recruiting NCT04003948 - Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification Phase 2
Active, not recruiting NCT03713983 - Treatment Outcomes Among Patients With Prescription Narcotic Drug Use Disorder
Active, not recruiting NCT02601495 - Latent Structure of Multi-level Assessments and Predictors of Outcomes for Women in Recovery
Recruiting NCT05534568 - The Oklahoma Parent-Child Assistance Program N/A
Completed NCT04907045 - An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care N/A
Completed NCT04268173 - Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3 Phase 3
Not yet recruiting NCT06317987 - Addressing Barriers to Care for Substance Use Disorder Pilot Study N/A
Active, not recruiting NCT06249542 - Implementing Screening for Cannabis and Other Drug Use Disorders in Primary Care: Impact on Diagnosis and Treatment N/A
Completed NCT02450240 - Latent Structure of Multi-level Assessments and Predictors of Outcomes in Psychiatric Disorders
Recruiting NCT03069118 - 90-Day Online Substance Use Program N/A
Active, not recruiting NCT05160233 - Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care N/A
Completed NCT03451344 - A Electronic System to Improve Recovery Outcomes in Patients With Drug Use Disorder N/A
Completed NCT00798538 - Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM) Phase 4
Completed NCT03684252 - Reducing Self-stigma in Persons With HIV and Drug Use Disorders in Primary Health Care Settings N/A