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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03013478
Other study ID # 1607018152
Secondary ID R01DA030369
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date August 31, 2018

Study information

Verified date September 2018
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date August 31, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard Treatment As Usual (TAU)
Treatment normally offered at this primary care clinic
CBT4CBT program


Locations

Country Name City State
United States Yale New Haven Hospital St Raphael's Campus 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 retention in treatment subjects returning for treatment at primary care unit and completing CBT4CBT program for those assigned 0 - 8 weeks
Primary reduction in drug use Using urine and breathalyzer screening for negative drug and alcohol testing 0 - 8 weeks
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