Substance AbuseNCT03013478
Computer Based Training in CBT in Primary Care
A study testing Standard Treatment As Usual (TAU) and CBT4CBT program in people with Substance Abuse, run by Yale University at 1 site in United States.
Trial summary
To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT to treatment as usual in a community based primary care program in a population of 60 individuals who meet current DSM criteria for substance use disorder other than nicotine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Standard Treatment As Usual (TAU) and CBT4CBT program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 31 Aug 2018
- Phase
- Interventional
- 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
- Are 18 years of age or older.
- Are applying for outpatient substance abuse treatment
- Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other stimulant use disorder
- Are sufficiently stable for 8 weeks of outpatient treatment
- Can commit to 8 weeks of treatment and are willing to be randomized to treatment
- Are willing to provide locator information.
Who cannot join
- Have an untreated bipolar or schizophrenic disorder
- Have a current legal case pending such that incarceration during the 8 week protocol is likely
- Are in need of detoxification from alcohol, opioids or benzodiazepines
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital St Raphael's Campus
New Haven, Connecticut, 06604
About this study
To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT to treatment as usual in a community based primary care program in a population of 60 individuals who meet current DSM criteria for substance use disorder other than nicotine.
Read the detailed description
The investigators will conduct an initial evaluation of the computer program as an enhancement of treatment as usual in a community-based primary care clinic. Sixty individuals with a current DSM-IV alcohol or substance use disorder will be randomly assigned to either (1) treatment as usual, or (2) treatment as usual plus exposure to the 'CBT for CBT' program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in drug use over 8 weeks. Secondary outcomes include treatment utilization
- Conditions
- Substance Abuse
- Being tested
- Standard Treatment As Usual (TAU), CBT4CBT program
- 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.
Standard Treatment As Usual (TAU)Behavioural
Treatment normally offered at this primary care clinic
CBT4CBT programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment as usual (TAU) | No intervention | Treatment normally offered at this primary care clinic |
| TAU plus CBT4CBT program | Active comparator | Treatment normally offered at this clinic PLUS 8 weeks of CBT4CBT computerized therapy. Receives: Behavioral: Standard Treatment As Usual (TAU); Behavioral: CBT4CBT program |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention in treatment
subjects returning for treatment at primary care unit and completing CBT4CBT program for those assigned
Measured: 0 - 8 weeks
reduction in drug use
Using urine and breathalyzer screening for negative drug and alcohol testing
Measured: 0 - 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startNov 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 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
- Kathleen M Carroll, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013478
- Sponsor's protocol ID
- 1607018152
- Other IDs
- R01DA030369
- Status last verified
- Sep 2018
- First submitted
- 4 Jan 2017
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Tetrault JM, Holt SR, Cavallo DA, O'Connor PG, Gordon MA, Corvino JK, Nich C, Carroll KM. Computerized Cognitive Behavioral Therapy for Substance Use Disorders in a Specialized Primary Care Practice: A Randomized Feasibility Trial to Address the RT Component of SBIRT. J Addict Med. 2020 Dec;14(6):e303-e309. doi: 10.1097/ADM.0000000000000663.
PubMed 32371660
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Based Training in CBT in Primary Care
- ClinicalTrials.gov ID
- NCT03013478
- Acronym / sponsor ID
- 1607018152
- Conditions
- Substance Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 6 Jan 2017 (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.
To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT to treatment as usual in a community based primary care program in a population of 60 individuals who meet current DSM criteria for substance use disorder other than nicotine.
Detailed description
The investigators will conduct an initial evaluation of the computer program as an enhancement of treatment as usual in a community-based primary care clinic. Sixty individuals with a current DSM-IV alcohol or substance use disorder will be randomly assigned to either (1) treatment as usual, or (2) treatment as usual plus exposure to the 'CBT for CBT' program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in drug use over 8 weeks. Secondary outcomes include treatment utilization
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment as usual (TAU) | No intervention | –Treatment normally offered at this primary care clinic |
| TAU plus CBT4CBT program | Active comparator | Behavioral: Standard Treatment As Usual (TAU), Behavioral: CBT4CBT programTreatment normally offered at this clinic PLUS 8 weeks of CBT4CBT computerized therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are 18 years of age or older.
- Are applying for outpatient substance abuse treatment
- Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other stimulant use disorder
- Are sufficiently stable for 8 weeks of outpatient treatment
- Can commit to 8 weeks of treatment and are willing to be randomized to treatment
Key exclusion criteria (3 listed)
- Have an untreated bipolar or schizophrenic disorder
- Have a current legal case pending such that incarceration during the 8 week protocol is likely
- Are in need of detoxification from alcohol, opioids or benzodiazepines
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 |
|---|---|---|
| Standard Treatment As Usual (TAU)Treatment normally offered at this primary care clinic | Behavioural | TAU plus CBT4CBT program |
| CBT4CBT program | Behavioural | TAU plus CBT4CBT program |
Primary outcome
retention in treatment
Time frame: 0 - 8 weeks
subjects returning for treatment at primary care unit and completing CBT4CBT program for those assigned
reduction in drug use
Time frame: 0 - 8 weeks
Using urine and breathalyzer screening for negative drug and alcohol testing
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 12 Sep 2018.
- Derived from this study: PubMed 32371660Tetrault JM, Holt SR, Cavallo DA, O'Connor PG, Gordon MA, Corvino JK, Nich C, Carroll KM. Computerized Cognitive Behavioral Therapy for Substance Use Disorders in a Specialized Primary Care Practice: A Randomized Feasibility Trial to Address the RT Component of SBIRT. J Addict Med. 2020 Dec;14(6):e303-e309. doi: 10.1097/ADM.0000000000000663.
- Individual participant dataSharing planned: Yes
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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.
Kathleen M Carroll, 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 Standard Treatment As Usual (TAU) and CBT4CBT program in people with Substance Abuse, 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 6 inclusion and 3 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 12 Sep 2018. 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. 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?
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?
retention in treatment (time frame: 0 - 8 weeks). The study lists 2 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 NCT03013478, which also lists 1 linked publication.
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 12 Sep 2018.