Cocaine Use DisorderPhase 1Project 1NCT02174614
The Effect of Cognitive Enhancement as a Precursor to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)
A Phase 1 study testing Treatment As Usual (TAU) and TAU plus Rapid Abstinence Initiation (RAI) in people with Cocaine Use Disorder, run by Yale University at 2 sites in United States.
Trial summary
The investigators are conducting a randomized clinical trial of rapid abstinence initiation and cognitive control training as a precursor to our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program to evaluate its effectiveness relative to standard outpatient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Treatment As Usual (TAU) and TAU plus Rapid Abstinence Initiation (RAI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to 31 Aug 2020
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Meet current DSM-5 criteria for cocaine use disorder
- Are sufficiently stable for 12 weeks of outpatient treatment
- Are willing to provide locator information for follow-up
- Are fluent in English
- Have a 6th grade or higher reading level for completion of assessments
Who cannot join
- Untreated bipolar or schizophrenic disorder
- Current suicide risk
- Have a legal case pending such that incarceration during the 12-week protocol is likely
- Are physically dependent on alcohol, opioids or benzodiazepines and require detoxification
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MCCA
Bridgeport, Connecticut, 06601
MCCA
New Haven, Connecticut, 06511
About this study
The investigators are conducting a randomized clinical trial of rapid abstinence initiation and cognitive control training as a precursor to our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program to evaluate its effectiveness relative to standard outpatient counseling at the Midwestern Connecticut Council of Alcoholism (MCCA). CCT will be used to assess attention, working memory and inhibitory control and the computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving cocaine abuse treatment.
Read the detailed description
150 cocaine dependent individuals will be randomly assigned to one of 3 conditions delivered over 4 weeks in the context of intensive outpatient treatment. 1. Treatment as Usual (TAU), 2. rapid abstinence initiation (RAI) or 3. computerized cognitive control training with escalating reinforcement for improved performance on training tasks (CCT). All participants will then receive an 8 week trial of CBT4CBT in addition to TAU. Follow up evaluation thru 6 months posttreatment will assess durability and delayed emergence of treatment effects.
- Conditions
- Cocaine Use Disorder
- Being tested
- Treatment As Usual (TAU), TAU plus Rapid Abstinence Initiation (RAI), TAU plus RAI plus Cognitive Control Training (CCT)
- Keywords
- Cocaine use disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment As Usual (TAU)Behavioural
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time.
TAU plus Rapid Abstinence Initiation (RAI)Behavioural
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment followed by 8 weeks of CBT4CBT computerized therapy.
TAU plus RAI plus Cognitive Control Training (CCT)Behavioural
Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment PLUS sessions of computerized cognitive control training (CCT) 3 times per week for the first 4 weeks followed by 8 weeks of CBT4CBT computerized therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time. Receives: Behavioral: Treatment As Usual (TAU) |
| TAU plus Rapid Abstinence Initiation (RAI) | Experimental | Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment Receives: Behavioral: Treatment As Usual (TAU); Behavioral: TAU plus Rapid Abstinence Initiation (RAI) |
| TAU plus RAI plus Cognitive Control Training (CCT) | Experimental | Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment PLUS sessions of computerized games 3 times per week for the first 4 weeks. Receives: Behavioral: Treatment As Usual (TAU); Behavioral: TAU plus Rapid Abstinence Initiation (RAI); Behavioral: TAU plus RAI plus Cognitive Control Training (CCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in cocaine use
Using urine and breathalyzer screening for negative cocaine and alcohol testing.
Measured: 12 weeks
Secondary outcomes (1)
Subjects ability to demonstrate coping skills acquisition through a computerized role-playing evaluation
Use of CBT4CBT program with acquisition of skills demonstrated through homework assignments.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startApr 2015
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Brian Kiluk, PhD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174614
- Sponsor's protocol ID
- 1405013937
- Other IDs
- 2P50DA009241-21
- Acronym
- Project 1
- Status last verified
- Oct 2020
- First submitted
- 23 Jun 2014
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Enhancement as a Precursor to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)
- ClinicalTrials.gov ID
- NCT02174614
- Acronym / sponsor ID
- Project 1 / 1405013937
- Conditions
- Cocaine Use Disorder
- Keywords
- Cocaine use disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2015 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 25 Jun 2014 (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 investigators are conducting a randomized clinical trial of rapid abstinence initiation and cognitive control training as a precursor to our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program to evaluate its effectiveness relative to standard outpatient counseling at the Midwestern Connecticut Council of Alcoholism (MCCA). CCT will be used to assess attention, working memory and inhibitory control and the computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving cocaine abuse treatment.
Detailed description
150 cocaine dependent individuals will be randomly assigned to one of 3 conditions delivered over 4 weeks in the context of intensive outpatient treatment. 1. Treatment as Usual (TAU), 2. rapid abstinence initiation (RAI) or 3. computerized cognitive control training with escalating reinforcement for improved performance on training tasks (CCT). All participants will then receive an 8 week trial of CBT4CBT in addition to TAU. Follow up evaluation thru 6 months posttreatment will assess durability and delayed emergence of treatment effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Behavioral: Treatment As Usual (TAU)Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time. |
| TAU plus Rapid Abstinence Initiation (RAI) | Experimental | Behavioral: Treatment As Usual (TAU), Behavioral: TAU plus Rapid Abstinence Initiation (RAI)Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment |
| TAU plus RAI plus Cognitive Control Training (CCT) | Experimental | Behavioral: Treatment As Usual (TAU), Behavioral: TAU plus Rapid Abstinence Initiation (RAI), Behavioral: TAU plus RAI plus Cognitive Control Training (CCT)Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment PLUS sessions of computerized games 3 times per week for the first 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Meet current DSM-5 criteria for cocaine use disorder
- Are sufficiently stable for 12 weeks of outpatient treatment
- Are willing to provide locator information for follow-up
- Are fluent in English
Key exclusion criteria (4 listed)
- Untreated bipolar or schizophrenic disorder
- Current suicide risk
- Have a legal case pending such that incarceration during the 12-week protocol is likely
- Are physically dependent on alcohol, opioids or benzodiazepines and require detoxification
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 |
|---|---|---|
| Treatment As Usual (TAU)Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time. | Behavioural | TAU plus RAI plus Cognitive Control Training (CCT), TAU plus Rapid Abstinence Initiation (RAI), Treatment As Usual (TAU) |
| TAU plus Rapid Abstinence Initiation (RAI)Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment followed by 8 weeks of CBT4CBT computerized therapy. | Behavioural | TAU plus RAI plus Cognitive Control Training (CCT), TAU plus Rapid Abstinence Initiation (RAI) |
| TAU plus RAI plus Cognitive Control Training (CCT)Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment PLUS sessions of computerized cognitive control training (CCT) 3 times per week for the first 4 weeks followed by 8 weeks of CBT4CBT computerized therapy. | Behavioural | TAU plus RAI plus Cognitive Control Training (CCT) |
Primary outcome
Reduction in cocaine use
Time frame: 12 weeks
Using urine and breathalyzer screening for negative cocaine and alcohol testing.
1 secondary outcome
Subjects ability to demonstrate coping skills acquisition through a computerized role-playing evaluation
Time frame: 12 weeks
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 14 Oct 2020.
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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.
Brian Kiluk, PhD study director
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment As Usual (TAU) and TAU plus Rapid Abstinence Initiation (RAI) in people with Cocaine Use Disorder, run by Yale University at 2 sites 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 6 inclusion and 4 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in cocaine use (time frame: 12 weeks). 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 14 Oct 2020.