Assessing Screening Plus Brief Intervention's Resulting Efficacy (ASPIRE) to Stop Drug Use - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Boston University Research Triangle Institute
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00876941

Purpose

The objective of this study is to test whether screening and brief intervention for drug use among primary care patients leads to improved drug-related outcomes (such as decreased drug use and consequences).

Condition	Intervention	Phase
Drug Usage Drug Abuse Drug Dependence	Behavioral: Standard Brief Intervention Behavioral: Enhanced Brief Intervention Behavioral: Control: Information and Feedback	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy/Effectiveness of Unhealthy Drug Use Screening/Brief Intervention Models

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Drug use [ Time Frame: Six Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Drug use consequences [ Time Frame: Six Months ] [ Designated as safety issue: No ]
HIV risk behaviors [ Time Frame: Six Months ] [ Designated as safety issue: No ]
Substance abuse treatment utilization [ Time Frame: Six Months ] [ Designated as safety issue: No ]
Costs [ Time Frame: Six Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	April 2009
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Standard Brief Intervention: Experimental	Behavioral: Standard Brief Intervention Intervention: Structured, brief negotiated interview. Intervention preparation and content: Preparation: review of ASSIST results; Content: The intervention involves 4 major parts: 1) establishing rapport and asking the subject for permission to raise the topic of drug use; 2) exploring the pros and cons of use; 3) providing feedback and assessing readiness to change; and 4) advising and negotiating a plan. Counselor: Health Promotion Advocate, High School graduate or GED minimum Training specific to the brief intervention: Didactic and experiential; competency demonstrated by observation and/or video recordings which are content scored using a standardized form. Contacts, Duration: One, 10-15 minutes. Communication content delivered to primary care physician: Results of screening and BI. Supervision: Weekly 1-hour meeting with supervisor to discuss job performance and discuss cases; biannual shadowing by supervisor.
Enhanced Brief Intervention: Experimental	Behavioral: Enhanced Brief Intervention Intervention: Less structured, motivational interview. Intervention preparation and content: Preparation: review of ASSIST, drug consequences (SIP-D), risk behaviors, CIDI Short Form, and medical record for discussion; Content: Motivational interviewing discussing above. Counselor: Master's level/Doctoral student. Training specific to the brief intervention: Didactic and experiential, followed by additional work towards, and confirmation of, proficiency using audio recordings coded for motivational interviewing content. Contacts, Duration: One plus offer of one optional booster contact, each 30-45 minutes; 2nd by telephone or in person depending on subject's preference; availability of counselor for further readiness discussions. Communication content delivered to primary care physician: Results of screening, BI, and plan including follow-up. Supervision: Weekly 1.5-hour meeting with supervisor with review of coded audio recordings.
Control: Active Comparator	Behavioral: Control: Information and Feedback Subjects randomized to the control group will not receive a BI at enrollment. But, all study subjects will receive screening and its results as part of the informed consent process (that they are at least at risk for drug use health hazards) along with a written list of resources available, including local options.

Detailed Description:

The efficacy of screening and brief intervention (SBI) for drug use among primary care patients is unknown. National organizations do not recommend universal screening. But policy is at odds with the evidence: federal efforts to disseminate SBI are underway, and reimbursement codes to compensate clinicians have been developed. Thus there is a need to study SBI for drug use. The objective of this study is to determine the efficacy of two models of brief intervention (BI) for decreasing drug use and consequences in primary care patients. In collaboration with a state project implementing SBI as part of a federal program, we will screen patients in a large hospital-based primary care practice for drug use. We will then enroll screen-positive subjects, randomly assign them to 1 of 3 groups, and follow them for 6 months. Subjects in 1 intervention group will be assigned to a standard BI model, conducted by trained health advocates implementing a Federal program locally. In another group, subjects will be assigned to an enhanced BI model that includes an optional booster contact and is conducted by master's-level counselors trained and monitored intensively. The control group will receive information (i.e., a written list of local resources to help people using drugs) and, at the end of six months, standard BI if they are still using drugs.

All subjects will be assessed regarding substance use and consequences, HIV risk behaviors, costs, healthcare utilization and receipt of substance dependence treatment. The primary outcome is drug use at 6 months; secondary outcomes are drug use consequences, including HIV risk behaviors, and receipt of substance dependence treatment (among those with dependence). We hypothesize that the standard BI and the enhanced BI will each have greater efficacy than screening and resource information alone for decreasing drug use, decreasing drug use consequences and HIV risk behaviors and increasing receipt of treatment for those with dependence.

Additionally, costs will also be compared. Results of this study re: efficacy and costs of brief intervention for drug use will be essential for making decisions about disseminating drug use SBI in primary care settings.

This study will enroll two cohorts:

We will enroll 450 subjects with an ASSIST Substance-Specific Involvement (SSI) Score of 4 or greater in order to test our primary hypotheses.

Primary analyses (i.e., effect of each BI on unhealthy drug use) will be restricted to subjects with an ASSIST SSI Score of 4 or greater.
We will enroll an additional 200 subjects with an ASSIST SSI Score of 2 or 3, indicating some, but lower risk drug use. Patients with these scores are included in clinical interventions, but because there are no data on effectiveness in the literature, this cohort will not be included in primary analyses and instead will be included only in secondary and exploratory analyses. We will examine potential preventive effects of BI (either) on subjects with lower level drug use.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older
Arrived for a visit in primary care
ASSIST Substance Specific Involvement Score of greater than or equal to 4 for subjects included in primary analyses; ASSIST Substance-Specific Involvement Scores of 2 or 3 for subjects included only in exploratory analyses
No previous MASBIRT intervention in the past 3 months
Fluent in English or Spanish
Two contacts who can assist with locating the subject for follow-up
Able to return to Boston Medical Center in the next 6 months for research study visits
Not pregnant (because care systems and resources differ greatly for such subjects)
Able to be interviewed by trained research staff (excluding those in acute discomfort or with significantly impaired cognition)

Exclusion Criteria:

NOT 18 years of age or older
NOT Arrived for a visit in primary care
NO ASSIST Substance Specific Involvement Score of greater than or equal to 4 for subjects included in primary analyses; or NO ASSIST Substance-Specific Involvement Scores of 2 or 3 for subjects included only in exploratory analyses
ANY previous MASBIRT intervention in the past 3 months
NOT Fluent in English or Spanish
FEWER THAN two contacts who can assist with locating the subject for follow-up
NOT able to return to Boston Medical Center in the next 6 months for research study visits
Pregnant (because care systems and resources differ greatly for such subjects)
UN-Able to be interviewed by trained research staff (excluding those in acute discomfort or with significantly impaired cognition)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876941

Contacts

Contact: Julie K Witas, MSW, MPH

617-414-6900

julie.witas@bmc.org

Locations

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Boston University

Research Triangle Institute

Investigators

Principal Investigator:

Richard Saitz, MD

Boston Medical Center

More Information

No publications provided

Responsible Party:	Boston Medical Center ( Richard Saitz, MD Principal Investigator )
Study ID Numbers:	DESPR DA025068, Grant Number: 1R01DA025068
Study First Received:	April 6, 2009
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00876941 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Drug
Drug Use
Screening

Brief Intervention
Primary Care
Utilization

Study placed in the following topic categories:

Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:

Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009