Clinical trial: Screening to Augment Referral to Treatment- Project START (NCT01539525)

Eligibility 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.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction