Alcohol AbuseProjectSTARTNCT01539525

Screening to Augment Referral to Treatment- Project START

A study testing Motivational Interview and Treatment as Usual in people with Alcohol Abuse and Tobacco Use Disorder, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 60 years, women only
Conditions the study is for: Alcohol Abuse, Tobacco Use Disorder, Marijuana Abuse
What is being tested?: Motivational Interview and Treatment as Usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 439 participants
Where: 2 sitesUnited States
Study dates: 5 Sep 2011to 28 Jan 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

In order to participate, women must meet the following criteria:
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).
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.
Have used their primary substance at least once within the prior 28 days.
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.

Who cannot join

Women are ineligible if they have any of the following criteria:
Are unable to speak English.
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).
Have a cognitive disorder that would impair their ability to provide informed consent or provide accurate information.
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.
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.

Show all 9Show fewer

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.
Have previously participated in this protocol or
Are unwilling to participate or accept randomization.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Yale-New Haven Hospital- York St Campus
New Haven, Connecticut, 06510
Yale-New Haven Hospital-Chapel St Campus
New Haven, Connecticut, 06519

Other trials in United States

About this study

Read the 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.

Conditions: Alcohol Abuse, Tobacco Use Disorder, Marijuana Abuse, Substance-Related Disorders
Being tested: Motivational Interview, Treatment as Usual
Medical subject headings: Alcoholism, Tobacco Use Disorder, Marijuana Abuse, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Motivational InterviewBehavioural
Motivational Interview provided by either a Nurse or Computer
Treatment as UsualOther
Subjects given a brochure listing relevant recovery resources in the local area.

Study groups in NCT01539525
Study group	Role	What they receive
Motivational Interview	Experimental	Motivational interview provided by a clinical research nurse or physician. Receives: Behavioral: Motivational Interview
Motivational Interview-Electronic	Active comparator	Motivational Interview provided by an interactive computer program. Receives: Behavioral: Motivational Interview
Treatment as Usual	Placebo comparator	No intervention- resource list provided. Receives: Other: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Days Per Month of Primary Substance Use
Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.
Measured: 7 non-overlapping monthly intervals from baseline to month 6
Treatment Utilization
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).
Measured: baseline to 6 months

Secondary outcomes (2)

Rates of STDs
rates of incident std's per patient's medical records
Measured: baseline to 6 months
Mean Cost for Each Intervention
The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 201128 Jan 2015

First posted27 Feb 2012 (estimated)
Study start5 Sep 2011
Primary completion28 Jan 2015
Study completion28 Jan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Alcohol 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 439 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01539525
Sponsor's protocol ID: 1005006785
Other IDs: R01DA027194
Acronym: ProjectSTART
Status last verified: Mar 2017
First submitted: 3 Aug 2011
Last updated: 14 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: We will require data request with delineation of variables of interest. Only de-identified data will be released after evaluation of the request

Publications

Forray A, Martino S, Gilstad-Hayden K, Kershaw T, Ondersma S, Olmstead T, Yonkers KA. Assessment of an electronic and clinician-delivered brief intervention on cigarette, alcohol and illicit drug use among women in a reproductive healthcare clinic. Addict Behav. 2019 Sep;96:156-163. doi: 10.1016/j.addbeh.2019.05.007. Epub 2019 May 8.
PubMed 31100713
Loree AM, Yonkers KA, Ondersma SJ, Gilstad-Hayden K, Martino S. Comparing satisfaction, alliance and intervention components in electronically delivered and in-person brief interventions for substance use among childbearing-aged women. J Subst Abuse Treat. 2019 Apr;99:1-7. doi: 10.1016/j.jsat.2019.01.007. Epub 2019 Jan 9.
PubMed 30797381

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Screening to Augment Referral to Treatment- Project START
ClinicalTrials.gov ID: NCT01539525
Acronym / sponsor ID: ProjectSTART / 1005006785
Conditions: Alcohol Abuse, Tobacco Use Disorder, Marijuana Abuse, Substance-Related Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 439 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 5 Sep 2011 (actual)
Primary completion: 28 Jan 2015 (actual)
Study completion: 28 Jan 2015 (actual)
First posted: 27 Feb 2012 (estimated)
Results: Posted 14 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

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

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Motivational Interview	Experimental	Behavioral: Motivational InterviewMotivational interview provided by a clinical research nurse or physician.
Motivational Interview-Electronic	Active comparator	Behavioral: Motivational InterviewMotivational Interview provided by an interactive computer program.
Treatment as Usual	Placebo comparator	Other: Treatment as UsualNo intervention- resource list provided.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

Are unable to speak English.
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).
Have a cognitive disorder that would impair their ability to provide informed consent or provide accurate information.
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.
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.

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
Motivational InterviewMotivational Interview provided by either a Nurse or Computer	Behavioural	Motivational Interview, Motivational Interview-Electronic
Treatment as UsualSubjects given a brochure listing relevant recovery resources in the local area.	Other	Treatment as Usual

Primary outcome

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.
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).

2 secondary outcomes

Rates of STDs
Time frame: baseline to 6 months
Mean Cost for Each Intervention
Time frame: 6 months

Results and safety

Results posted to the registry on 14 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Motivational Interview-Nurse	145	125
Motivational Interview-Computer	143	127
Treatment as Usual	151	134

Primary outcome: Days Per Month of Primary Substance Use

Time frame: 7 non-overlapping monthly intervals from baseline to month 6. Mean (Standard Deviation). Unit: days per month

Measure	Motivational Interview-Nurse n = 145	Motivational Interview-Computer n = 143	Treatment as Usual n = 151
baseline	23.2 (8.3)	23.7 (7.7)	24.2 (7.7)
Month 1	19.3 (11.2)	19.7 (11.2)	22.8 (8.9)
Month 2	18.7 (11.8)	17.9 (12.1)	22.2 (10.1)
Month 3	18.0 (12.0)	17.8 (11.9)	21.4 (10.6)
Month 4	18.0 (12.2)	16.8 (12.3)	20.0 (11.4)
Month 5	17.6 (12.5)	16.3 (12.6)	19.7 (11.4)
Month 6	17.0 (12.3)	16.2 (12.5)	19.1 (11.8)

Motivational Interview-Nurse vs Motivational Interview-Computer vs Treatment as Usual: Slope: -0.078 (95% CI -0.118 to -0.038), p <0.001, Generalized Estimating Equation
Motivational Interview-Nurse vs Motivational Interview-Computer vs Treatment as Usual: Slope: 0.005 (95% CI -0.0004 to 0.011), p = 0.066, Generalized Estimating Equation
Motivational Interview-Nurse vs Motivational Interview-Computer vs Treatment as Usual: Slope: -0.078 (95% CI -0.151 to -0.004), p = 0.038, Generalized Estimating Equation

Primary outcome: Treatment Utilization

Time frame: baseline to 6 months. Number. Unit: participants

Measure	Motivational Interview-Nurse n = 145	Motivational Interview-Computer n = 143	Treatment as Usual n = 151
utilized treatment	39	39	43
no tretment	106	104	108

Motivational Interview-Nurse vs Motivational Interview-Computer vs Treatment as Usual: Odds Ratio (OR): 0.931 (95% CI 0.559 to 1.551), p = 0.810, Regression, Logistic
Motivational Interview-Nurse vs Motivational Interview-Computer vs Treatment as Usual: Odds Ratio (OR): 0.968 (95% CI 0.579 to 1.617), p = 0.990, Regression, Logistic

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Motivational Interview	0 of 145 (0%)	0 of 145 (0%)	Not reported
Motivational Interview-Electronic	0 of 143 (0%)	0 of 143 (0%)	Not reported
Treatment as Usual	0 of 151 (0%)	0 of 151 (0%)	Not reported

Limitations and caveats (from the sponsor): Results may not be generalizable to populations differing from population from which sample was drawn. Outcomes relied upon self-report, although we did try to verify through lab results for substance use and medical records/ provider for treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31100713Forray A, Martino S, Gilstad-Hayden K, Kershaw T, Ondersma S, Olmstead T, Yonkers KA. Assessment of an electronic and clinician-delivered brief intervention on cigarette, alcohol and illicit drug use among women in a reproductive healthcare clinic. Addict Behav. 2019 Sep;96:156-163. doi: 10.1016/j.addbeh.2019.05.007. Epub 2019 May 8.
Derived from this study: PubMed 30797381Loree AM, Yonkers KA, Ondersma SJ, Gilstad-Hayden K, Martino S. Comparing satisfaction, alliance and intervention components in electronically delivered and in-person brief interventions for substance use among childbearing-aged women. J Subst Abuse Treat. 2019 Apr;99:1-7. doi: 10.1016/j.jsat.2019.01.007. Epub 2019 Jan 9.
Individual participant dataSharing planned: No. We will require data request with delineation of variables of interest. Only de-identified data will be released after evaluation of the request

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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.

Kimberly A Yonkers, MD principal investigator

Yale University

Steve Martino, PhD principal investigator

Yale University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interview and Treatment as Usual in people with Alcohol Abuse and Tobacco Use Disorder, run by Yale University at 2 sites 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 5 inclusion and 9 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 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Days Per Month of Primary Substance Use (time frame: 7 non-overlapping monthly intervals from baseline to month 6). 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 NCT01539525, which also lists 2 linked publications.

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 14 Apr 2017.