We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Screening to Augment Referral to Treatment- Project START (ProjectSTART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01539525
Recruitment Status : Completed
First Posted : February 27, 2012
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Alcohol Abuse Tobacco Use Disorder Marijuana Abuse Substance-Related Disorders Behavioral: Motivational Interview Other: Treatment as Usual

Detailed 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 439 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Participants received a behavioral intervention that could not be masked. Outcome data were self report and urine tests rom the participants.
Primary Purpose: Treatment
Official Title: Screening to Augment Referral to Treatment- Project START
Actual Study Start Date : September 5, 2011
Primary Completion Date : January 28, 2015
Study Completion Date : January 28, 2015
Arms and Interventions

Arm Intervention/treatment
Experimental: Motivational Interview
Motivational interview provided by a clinical research nurse or physician.
Behavioral: Motivational Interview
Motivational Interview provided by either a Nurse or Computer
Active Comparator: Motivational Interview-Electronic
Motivational Interview provided by an interactive computer program.
Behavioral: Motivational Interview
Motivational Interview provided by either a Nurse or Computer
Placebo Comparator: Treatment as Usual
No intervention- resource list provided.
Other: Treatment as Usual
Subjects given a brochure listing relevant recovery resources in the local area.


Outcome Measures

Primary Outcome Measures :
  1. Days Per Month of Primary Substance Use [ Time Frame: 7 non-overlapping monthly intervals from baseline to month 6 ]
    Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.

  2. Treatment Utilization [ Time Frame: baseline to 6 months ]
    Treatment utilization assessed via participant self-report at each follow-up interview, and with the exception of self-help groups, verified with providers. We also reviewed the medical record for use of medication indicative of treatment (e.g., nicotine replacement therapy).


Secondary Outcome Measures :
  1. Rates of STDs [ Time Frame: baseline to 6 months ]
    rates of incident std's per patient's medical records

  2. Mean Cost for Each Intervention [ Time Frame: 6 months ]
    The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539525


Locations
United States, Connecticut
Yale-New Haven Hospital- York St Campus
New Haven, Connecticut, United States, 06510
Yale-New Haven Hospital-Chapel St Campus
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kimberly A Yonkers, MD Yale School of Medicine
Principal Investigator: Steve Martino, PhD Yale School of Medicine
More Information

Responsible Party: Kimberly Yonkers, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01539525     History of Changes
Other Study ID Numbers: 1005006785
R01DA027194 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2012    Key Record Dates
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will require data request with delineation of variables of interest. Only de-identified data will be released after evaluation of the request

Additional relevant MeSH terms:
Disease
Alcoholism
Substance-Related Disorders
Tobacco Use Disorder
Marijuana Abuse
Pathologic Processes
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders