Screening to Augment Referral to Treatment- Project START

Tobacco Use Disorder Clinical Trial

— ProjectSTART  

Official title:

Screening to Augment Referral to Treatment- Project START

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01539525
• Other study ID #: 1005006785
• Secondary ID: R01DA027194
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 3, 2011
• Last updated: February 9, 2016
• Start date: September 2010
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The investigators propose to use obstetric-gynecological clinics to conduct a randomized clinical trial that would compare two SBIRTS (Screening, Brief Intervention, Referral and Treatment), delivered either by a trained nurse or by computer, to usual care (a control condition). As part of this trial, the investigators will include outcomes that allow us to assess the cost effectiveness of these three conditions.

Description:

Aim 1: To assess whether SBIRT, based upon motivational interviewing and delivered either by computer or a trained nurse, leads to decreased use of a subject's primary drug of abuse.

Hypothesis #1a: Referrals based upon motivational principles and delivered by computer, as compared to usual care (health brochure with treatment resources), will lead to greater reductions in a woman's primary substance of abuse.

Hypothesis #1b: Referrals based upon motivational principles and delivered by nurse, as compared to usual care (health brochure with treatment resources), will lead to greater reductions in a woman's primary substance of abuse.

Aim 2: To determine whether SBIRT based upon motivational interviewing and delivered either by computer or by a nurse will promote substance abuse treatment utilization for the primary drug of abuse.

Hypothesis #2a: Treatment utilization (eg. treatment initiation, attendance, use of quit-line or medication) will be higher if a woman receives the computer delivered brief intervention than if she receives usual care only.

Hypothesis #2b: Treatment utilization (eg. treatment initiation, attendance, use of quit-line or medication) will be higher if a woman receives the nurse delivered brief intervention than if she receives usual care only.

Secondary Aim 3: To evaluate whether SBI leads to a decrease in HIV/AIDS risk

Hypothesis #3: Rates of sexually transmitted diseases, injection drug use and risky sexual behavior will be lower at follow up for subjects who receive either computer or a nurse delivered brief intervention than usual care subjects.

Secondary Aim 4: To compare the relative cost-effectiveness of the three interventions.

Hypothesis #4a: Screening and usual care will be the most cost-effective intervention method when the value of an additional unit of effect for the given individual's outcome is relatively low.

Hypotheses #4b: Screening, and a brief intervention delivered by computer, will be the most cost-effective treatment method when the value of an additional unit of effect is relatively high.

Hypotheses #4c: Screening, and a brief intervention delivered by a nurse, will be less cost-effective than a brief intervention delivered by computer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 495
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

In order to participate, women must meet the following criteria:

1. Are non-pregnant and meet ASSIST criteria for at least moderate risk for alcohol (=11) or drug (=4) abuse or dependence (tobacco or illicit drugs, including cocaine, opiates, methamphetamine, marijuana or a prescription drug used in a medically inappropriate manner).

2. Are pregnant and meet ASSIST criteria for at least mild to moderate risk for alcohol (=6) or drug (=4) abuse or dependence (alcohol, tobacco, an illicit drug, or a prescription drug in a medically inappropriate manner). We define pregnant women who use alcohol or drugs at least monthly in the last 90 days as eligible because alcohol and many of the other substances (eg. tobacco) are teratogens and use in pregnancy would be consistent with a diagnosis of abuse ("recurrent use in situations in which it is physically hazardous"). This level of use in pregnancy also indicates a greater likelihood of problematic substance use.

3. Have used their primary substance at least once within the prior 28 days.

4. Are aged 18 or more. We include participants who are aged 18 or older because parents may not be available at screening to provide consent for non-pregnant participants and subjects may not wish to disclose drug or alcohol abuse to a parent.

Exclusion Criteria:

Women are ineligible if they have any of the following criteria:

1. Are unable to speak English.

2. Are incarcerated or at risk of incarceration. The YNHH Women's Center provides care to incarcerated women. These individuals as well as those at risk of incarceration are excluded because incarceration precludes their ability to seek specialty drug or alcohol abuse treatment (a dependent measure).

3. Have a cognitive disorder that would impair their ability to provide informed consent or provide accurate information.

4. Require immediate hospitalization because of general medical needs or due to active suicidal or homicidal ideation or other behavioral health problems. We exclude individuals who are in need of immediate hospitalization because hospitalization will render it more difficult for them to immediately follow-up on a referral and because providers, rather than subjects, may be making the decision to initiate treatment. Hospitalization would also potentially force women who smoke to initiate treatment for tobacco addiction.

5. Are currently participating or have participated in drug abuse treatment, including self-help interventions (eg. 12 step facilitation, smoking cessation interventions), within the last 3 months prior to screening.

6. Are planning to relocate out of the area in the following 6 months. Women who relocate out of the area would be difficult to see for follow up assessments and it would be difficult to confirm treatment attendance in local treatment centers.

7. Have previously participated in this protocol or

8. Are unwilling to participate or accept randomization.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Disease
• Marijuana Abuse
• Substance-Related Disorders
• Tobacco Use Disorder

Intervention

Behavioral:
• Motivational Interview
Motivational Interview provided by either a Nurse or Computer

Other:
• Resource brochure
Subjects given a brochure listing relevant recovery resources in the local area.

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital- York St Campus	New Haven	Connecticut
United States	Yale-New Haven Hospital-Chapel St 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	Substance use	Decrease in subject's primary drug of abuse	6 months	No
Primary	Treatment utilization	Increase in subjects' treatment utilization	6 months	No
Secondary	Rates of STDs	Decreased rates of sexually transmitted diseases	6 months	No
Secondary	Improved cost-effectiveness	Incremental cost-effectiveness ratios (ICERs) will be calculated separately for the societal perspective and the payer's perspective. ICERs measure the incremental cost of using a given intervention, compared to the next-least-costly intervention, to produce an extra unit of effect for each of the patient outcomes (e.g., an additional patient initiating treatment, an additional week of abstinence).	6 months	No

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