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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier:
NCT01539525
First received: August 3, 2011
Last updated: March 2, 2017
Last verified: March 2017
Results First Received: September 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Alcohol Abuse
Tobacco Use Disorder
Marijuana Abuse
Substance-Related Disorders
Interventions: Behavioral: Motivational Interview
Other: Treatment as Usual

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were women (non-pregnant and pregnant) presenting for outpatient reproductive healthcare in an urban academic hospital-based clinic. Data collection occurred between April 20, 2011 and January 28, 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Motivational Interview-Nurse

Motivational interview provided by a clinical research nurse or physician.

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

Motivational Interview-Computer

Motivational Interview provided by an interactive computer program.

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

Treatment as Usual

No intervention- resource list provided.

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


Participant Flow:   Overall Study
    Motivational Interview-Nurse   Motivational Interview-Computer   Treatment as Usual
STARTED   145   143   151 
COMPLETED   125   127   134 
NOT COMPLETED   20   16   17 
Lost to Follow-up                19                12                11 
Withdrawal by Subject                0                3                2 
Protocol Violation                1                1                4 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Motivational Interview

Motivational interview provided by a clinical research nurse or physician.

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

Motivational Interview-Electronic

Motivational Interview provided by an interactive computer program.

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

Treatment as Usual

No intervention- resource list provided.

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

Total Total of all reporting groups

Baseline Measures
   Motivational Interview   Motivational Interview-Electronic   Treatment as Usual   Total 
Overall Participants Analyzed 
[Units: Participants]
 145   143   151   439 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.6  (109)   34.6  (10.3)   34.4  (12.0)   34.2  (11.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      145 100.0%      143 100.0%      151 100.0%      439 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
       
Afican-American, non-Hispanic   102   93   98   293 
Caucasian-American, non-Hispanic   19   16   23   58 
Hispanic   19   22   24   65 
Other race/ethnicity   5   12   6   23 
Marital Status 
[Units: Participants]
       
Married/living with partner   70   54   73   197 
Other living situation   75   89   78   242 
Pregnant 
[Units: Participants]
       
Pregnant   27   24   29   80 
Not pregnant   118   119   122   359 
Education 
[Units: Participants]
       
Some high school or less   46   48   52   146 
High school graduate   64   60   57   181 
Beyond high school   35   33   42   110 
missing   0   2   0   2 
Employment status 
[Units: Participants]
       
Full-time   18   28   20   66 
Part-time   24   26   32   82 
Not working   103   89   99   291 
Primary Substance 
[Units: Participants]
       
Nicotine   81   80   90   251 
Alcohol   15   23   13   51 
Cannabis   32   27   31   90 
Other illicit drug   17   13   17   47 
Primary substance use 
[Units: Days per month]
Mean (Standard Deviation)
 23.2  (8.3)   23.7  (7.7)   24.2  (7.7)   23.7  (7.9) 
Any substance use 
[Units: Days per month]
Mean (Standard Deviation)
 26.0  (5.5)   25.4  (6.2)   25.7  (6.1)   25.7  (5.9) 
Substance Use Disorders 
[Units: Participants]
       
Nicotine   81   80   90   251 
Alcohol   15   23   13   51 
Cannabis   32   27   31   90 
Other illicit drug   17   13   17   47 
Alcohol, Smoking, and Substance Involvement Screening Test Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 22.5  (8.1)   22.8  (8.5)   22.2  (8.1)   22.5  (7.9) 
[1] Scores range from 0 to 39, with higher scores indicating greater need for more intensive intervention. Scores are for primary substance.
Fagerstrom Test for Nicotine Dependence Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.8  (2.7)   3.6  (2.8)   3.9  (2.7)   3.9  (2.6) 
[1] Scores range from 0 to 10, with higher scores indicating higher levels of nicotine dependence.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Days Per Month of Primary Substance Use   [ Time Frame: 7 non-overlapping monthly intervals from baseline to month 6 ]

2.  Primary:   Treatment Utilization   [ Time Frame: baseline to 6 months ]

3.  Secondary:   Rates of STDs   [ Time Frame: baseline to 6 months ]

4.  Secondary:   Mean Cost for Each Intervention   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kimberly A Yonkers
Organization: Yale University School of Medicine
phone: 203-764-6621
e-mail: kimberly.yonkers@yale.edu



Responsible Party: Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier: NCT01539525     History of Changes
Other Study ID Numbers: 1005006785
R01DA027194 ( U.S. NIH Grant/Contract )
Study First Received: August 3, 2011
Results First Received: September 29, 2016
Last Updated: March 2, 2017