Drug Use DisordersNCT03373240

Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention

A study testing TAU plus Cognitive Remediation Program in people with Drug Use Disorders, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Drug Use Disorders
What is being tested?: TAU plus Cognitive Remediation Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 1 siteUnited States
Study dates: 22 Jan 2018to 17 Oct 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Substance Abuse Treatment Center (SATU)
New Haven, Connecticut, 06511

Other trials in United States

About this study

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.

Read the detailed 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.

Conditions: Drug Use Disorders
Being tested: TAU plus Cognitive Remediation Program, TAU plus Control Tasks
Keywords: Drug use Disorders, Cognitive Remediation
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.

TAU plus Cognitive Remediation ProgramBehavioural
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 TasksBehavioural
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.

Study groups in NCT03373240
Study group	Role	What they receive
TAU plus Cognitive Remediation Program	Experimental	Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making. Receives: Behavioral: TAU plus Cognitive Remediation Program
TAU plus Control Tasks	Placebo comparator	Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games. Receives: Behavioral: TAU plus Control Tasks

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Training visit 1 through 4 weeks of training
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.
Measured: 4 weeks before First Training Session through the 4-week training period
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.
Measured: from the week prior to training to the week after training
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).
Measured: Training visit 1 through 4 weeks of training
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).
Measured: Training visit 1 through 4 weeks of training
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.
Measured: from the week prior to training (pre) to the week after training (post)
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.
Measured: from the week prior to training (pre) to the week after training (post)
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.
Measured: from the week prior to training (pre) to the week after training (post)
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.
Measured: from the week prior to training (pre) to the week after training (post)
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
Measured: from the week prior to training (pre) to the week after training (post)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 201817 Oct 2019

First posted14 Dec 2017
Study start22 Jan 2018
Primary completion17 Oct 2019
Study completion17 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Drug Use DisordersStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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).
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03373240
Sponsor's protocol ID: 2000021496
Other IDs: 2P50DA009241-21
Status last verified: Dec 2020
First submitted: 8 Dec 2017
Last updated: 8 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention
ClinicalTrials.gov ID: NCT03373240
Acronym / sponsor ID: 2000021496
Conditions: Drug Use Disorders
Keywords: Drug use Disorders, Cognitive Remediation
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 22 Jan 2018 (actual)
Primary completion: 17 Oct 2019 (actual)
Study completion: 17 Oct 2019 (actual)
First posted: 14 Dec 2017 (actual)
Results: Posted 8 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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).

Arm	Type	Receives
TAU plus Cognitive Remediation Program	Experimental	Behavioral: TAU plus Cognitive Remediation ProgramTreatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Control Tasks	Placebo comparator	Behavioral: TAU plus Control TasksTreatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

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
TAU plus Cognitive Remediation ProgramTreatment 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.	Behavioural	TAU plus Cognitive Remediation Program
TAU plus Control TasksTreatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.	Behavioural	TAU plus Control Tasks

Primary outcome

Change in Stop Signal Reaction Time
Time frame: Training visit 1 through 4 weeks of training
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.
Change From Pre-Post in Substance Use
Time frame: 4 weeks before First Training Session through the 4-week training period
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.
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)
Time frame: from the week prior to training to the week after training
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.
Change in Experimental Performance-Change in Percentage of Risky Choices Under Risk Condition of the Lottery Task
Time frame: Training visit 1 through 4 weeks of training
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).
Change in Experimental Performance- Change in Percentage of Ambiguous Choices Under 24% Ambiguity in Lottery Task
Time frame: Training visit 1 through 4 weeks of training
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).
Change in Experimental Performance- Paced Auditory Serial Addition Test (PASAT)
Time frame: from the week prior to training (pre) to the week after training (post)
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.
Change in Pre-Post Cognitive Affective Battery: Digit Backwards
Time frame: from the week prior to training (pre) to the week after training (post)
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.
Change in Pre-Post Cognitive Affective Battery: Breath Holding
Time frame: from the week prior to training (pre) to the week after training (post)
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.
Change in Pre-Post Cognitive Affective Battery: Perceived Stress Scale
Time frame: from the week prior to training (pre) to the week after training (post)
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.
Change in Pre-Post Cognitive Affective Battery: Delay Discounting
Time frame: from the week prior to training (pre) to the week after training (post)
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

Results and safety

Results posted to the registry on 8 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAU Plus Cognitive Remediation Program	22	11
TAU Plus Control Tasks	24	20

Primary outcome: Change in Stop Signal Reaction Time

Time frame: Training visit 1 through 4 weeks of training. Mean (Standard Error). Unit: ms

Measure	TAU Plus Cognitive Remediation Program n = 21	TAU Plus Control Tasks n = 0
Value	-8.62 (2.79)	–

TAU Plus Cognitive Remediation Program: Mean Difference (Net): -8.62 (95% CI -14.17 to -3.06), p = .003, Mixed Models Analysis

Population analysed: All participants who completed one or more sessions of the computerized Stop Signal task. Negative change reflects improved inhibition over time.

Primary outcome: Change From Pre-Post in Substance Use

Time frame: 4 weeks before First Training Session through the 4-week training period. Mean (Standard Error). Unit: cube root (number of days)

Measure	TAU Plus Cognitive Remediation Program n = 15	TAU Plus Control Tasks n = 19
Value	-.34 (.19)	.19 (.17)

TAU Plus Cognitive Remediation Program vs TAU Plus Control Tasks: Mean Difference (Net): -.075 (95% CI -.333 to .184), p = .049, ANOVA

Population analysed: All participants who completed the pre- and post-treatment substance use calendar.

Primary outcome: 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)

Time frame: from the week prior to training to the week after training. Mean (Standard Error). Unit: score on scale

Measure	TAU Plus Cognitive Remediation Program n = 15	TAU Plus Control Tasks n = 23
Value	-3.13 (1.57)	-.70 (1.27)

TAU Plus Cognitive Remediation Program vs TAU Plus Control Tasks: Mean Difference (Net): -1.914 (95% CI -3.965 to .136), p = .236, ANOVA

Population analysed: All participants who completed the UPPS-NU for both pre- and post-treatment cognitive-affective battery

Primary outcome: Change in Experimental Performance-Change in Percentage of Risky Choices Under Risk Condition of the Lottery Task

Time frame: Training visit 1 through 4 weeks of training. Mean (Standard Error). Unit: percent of risky choices

Measure	TAU Plus Cognitive Remediation Program n = 20	TAU Plus Control Tasks n = 0
Value	-1.62 (0.77)	–

TAU Plus Cognitive Remediation Program: Mean Difference (Net): -1.62 (95% CI -3.15 to -.08), p = .039, Mixed Models Analysis

Population analysed: All participants who completed one or more sessions of the Lottery Task. Negative change indicated improved decision-making

Adverse events

Time frame: 2 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAU Plus Cognitive Remediation Program	2 of 22 (9.1%)	0 of 22 (0%)	0 of 22
TAU Plus Control Tasks	1 of 24 (4.2%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

Arielle Baskin-Sommers, PhD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TAU plus Cognitive Remediation Program in people with Drug Use Disorders, run by Yale University 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 4 inclusion and 6 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 8 Jan 2021. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Stop Signal Reaction Time (time frame: Training visit 1 through 4 weeks of training). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03373240.

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 8 Jan 2021.