Alcohol AbusePhase 2PRIDE-PNCT00227903

Therapeutic Substance Abuse Treatment in Pregnancy - 1

A Phase 2 study testing MI-CBT and Brief Advice in people with Alcohol Abuse and Cocaine Abuse, 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

Search all trials

Trial summary

Who is it for?: Ages 16 to 45 years, women only
Conditions the study is for: Alcohol Abuse, Cocaine Abuse, Marijuana Abuse
What is being tested?: MI-CBT and Brief Advice
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 168 participants
Where: 2 sitesUnited States
Study dates: Sep 2004to Aug 2010
Phase: Phase 2
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 16 to 45 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

Pregnant women, age 16 or older, alcohol or illicit drug use in the past 30 days -

Who cannot join

Nonfluent in English or Spanish, pending incarceration, psychotic, cognitively unable to give informed consent, actively suicidal or homicidal, already engaged in addictions treatment, primarily addicted to nicotine or heroin.
-

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Bridgeport Hospital
Bridgeport, Connecticut, 06106
Yale-New Haven Hospital
New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)

The purpose of this study is... To assess whether a behavioral treatment that combines motivational enhancement and cognitive skills training therapy (MET-CBT) is more effective than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g. marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using and dependent women; 2) decreasing HIV risk behavior; 3) improving birth outcomes (longer gestations and greater birth weight).

Read the detailed description

We propose an integrated system of counseling services onsite in primary care obstetrical clinics, comparing a manualized brief advice (closely approximating "treatment as usual") to manualized motivationally enhanced cognitive behavioral therapy. Treatment providers are obstetrical nurses. Therapy patients are taught skill sets designed to enhance motivation to abstain from drugs of abuse, as well as designed to prevent relapse during the perinatal period. It is our hypothesis that therapy patients will be more successful at achieving stated study aims than those receiving brief advice.

Conditions: Alcohol Abuse, Cocaine Abuse, Marijuana Abuse
Being tested: MI-CBT, Brief Advice
Medical subject headings: Alcoholism, Cocaine-Related Disorders, Marijuana Abuse

What participants receive

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

MI-CBTBehavioural
Motivationally-enhanced cognitive behavioral skills counseling
Brief AdviceBehavioural
Advice and education

Study groups in NCT00227903
Study group	Role	What they receive
MI-CBT	Experimental	Motivationally-enhanced cognitive behavioral skills counseling Receives: Behavioral: MI-CBT
Brief Advice	Active comparator	Advice and education Receives: Behavioral: Brief Advice

What is being measured

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

Percentage of Days Used Drugs or Alcohol
Measured: intake to delivery, an average of 21 weeks
Percentage of Days Used Drugs or Alcohol
Measured: delivery to 3 months post-delivery
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Measured: intake to delivery, an average of 21 weeks
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Measured: Delivery to 3 months post-delivery
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Measured: intake to delivery, an average of 21 weeks
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Measured: Delivery to 3 months post-delivery

Secondary outcomes (20)

Incidence of Preterm Births
Measured: At delivery
Incidence of Low Birth Weight
Measured: At delivery
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Measured: intake to delivery, an average of 21 weeks
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Measured: Delivery to 3 months post-delivery
Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine
Measured: intake to delivery, an average of 21 weeks
Proportion of Participants Abstinent From Drugs According to Urine
Based on urine tests for marijuana, cocaine, or opioids
Measured: Delivery to 3 months post-delivery
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Based on urine tests for marijuana, cocaine or opioids.
Measured: intake to delivery, an average of 21 weeks
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Based on urine tests for marijuana, cocaine, or opioids.
Measured: Delivery to 3 months post-delivery
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Measured: intake to delivery, an average of 21 weeks
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Measured: Delivery to 3 months post-delivery
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Measured: intake to delivery, an average of 21 weeks
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Measured: Delivery to 3 months post-delivery
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Based on urine tests for marijuana, cocaine or opioids.
Measured: intake to delivery, an average of 21 weeks
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Based on urine tests for marijuana, cocaine or opioids.
Measured: Delivery to 3 months post-delivery
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Based on urine tests for marijuana, cocaine or opioids.
Measured: intake to delivery, an average of 21 weeks
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Based on urine tests for marijuana, cocaine or opioids.
Measured: Delivery to 3 months post-delivery
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Based on urine tests for marijuana, cocaine or opioids.
Measured: intake to delivery, an average of 21 weeks
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Based on urine tests for marijuana, cocaine or opioids
Measured: Delivery to 3 months post-delivery
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Based on urine tests for marijuana, cocaine or opioids
Measured: intake to delivery, an average of 21 weeks
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Based on urine tests for marijuana, cocaine or opioids
Measured: Delivery to 3 months post-delivery

Timeline

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

Sep 2004Aug 2010

First posted28 Sep 2005 (estimated)
Study startSep 2004
Primary completionAug 2010
Study completionAug 2010

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 (7)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00227903
Sponsor's protocol ID: 0402026466
Other IDs: R01DA019135
Acronym: PRIDE-P
Status last verified: Apr 2020
First submitted: 27 Sep 2005
Last updated: 15 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: only aggregate de-identified data

Publications

Yonkers KA, Howell HB, Allen AE, Ball SA, Pantalon MV, Rounsaville BJ. A treatment for substance abusing pregnant women. Arch Womens Ment Health. 2009 Aug;12(4):221-7. doi: 10.1007/s00737-009-0069-2. Epub 2009 Apr 7.
PubMed 19350369
Hine CE, Howell HB, Yonkers KA. Integration of medical and psychological treatment within the primary health care setting. Soc Work Health Care. 2008;47(2):122-34. doi: 10.1080/00981380801970244.
PubMed 18956504
Yonkers KA, Gotman N, Kershaw T, Forray A, Howell HB, Rounsaville BJ. Screening for prenatal substance use: development of the Substance Use Risk Profile-Pregnancy scale. Obstet Gynecol. 2010 Oct;116(4):827-833. doi: 10.1097/AOG.0b013e3181ed8290.
PubMed 20859145
Quesada O, Gotman N, Howell HB, Funai EF, Rounsaville BJ, Yonkers KA. Prenatal hazardous substance use and adverse birth outcomes. J Matern Fetal Neonatal Med. 2012 Aug;25(8):1222-7. doi: 10.3109/14767058.2011.602143. Epub 2012 May 11.
PubMed 22489543
Yonkers KA, Forray A, Howell HB, Gotman N, Kershaw T, Rounsaville BJ, Carroll KM. Motivational enhancement therapy coupled with cognitive behavioral therapy versus brief advice: a randomized trial for treatment of hazardous substance use in pregnancy and after delivery. Gen Hosp Psychiatry. 2012 Sep-Oct;34(5):439-49. doi: 10.1016/j.genhosppsych.2012.06.002. Epub 2012 Jul 12.
PubMed 22795046
Xu X, Yonkers KA, Ruger JP. Economic evaluation of a behavioral intervention versus brief advice for substance use treatment in pregnant women: results from a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Mar 7;17(1):83. doi: 10.1186/s12884-017-1260-5.
PubMed 28270105
Forray A, Gotman N, Kershaw T, Yonkers KA. Perinatal smoking and depression in women with concurrent substance use. Addict Behav. 2014 Apr;39(4):749-56. doi: 10.1016/j.addbeh.2013.12.008. Epub 2013 Dec 17.
PubMed 24447885

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)
ClinicalTrials.gov ID: NCT00227903
Acronym / sponsor ID: PRIDE-P / 0402026466
Conditions: Alcohol Abuse, Cocaine Abuse, Marijuana Abuse
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Sep 2004
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 28 Sep 2005 (estimated)
Results: Posted 21 Aug 2013

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MI-CBT	Experimental	Behavioral: MI-CBTMotivationally-enhanced cognitive behavioral skills counseling
Brief Advice	Active comparator	Behavioral: Brief AdviceAdvice and education

Who may qualify

Ages: 16 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Pregnant women, age 16 or older, alcohol or illicit drug use in the past 30 days -

Key exclusion criteria (2 listed)

Nonfluent in English or Spanish, pending incarceration, psychotic, cognitively unable to give informed consent, actively suicidal or homicidal, already engaged in addictions treatment, primarily addicted to nicotine or heroin.
-

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
MI-CBTMotivationally-enhanced cognitive behavioral skills counseling	Behavioural	MI-CBT
Brief AdviceAdvice and education	Behavioural	Brief Advice

Primary outcome

Percentage of Days Used Drugs or Alcohol
Time frame: intake to delivery, an average of 21 weeks
Percentage of Days Used Drugs or Alcohol
Time frame: delivery to 3 months post-delivery
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Time frame: intake to delivery, an average of 21 weeks
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Time frame: Delivery to 3 months post-delivery
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Time frame: intake to delivery, an average of 21 weeks
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Time frame: Delivery to 3 months post-delivery

20 secondary outcomes

Incidence of Preterm Births
Time frame: At delivery
Incidence of Low Birth Weight
Time frame: At delivery
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time frame: Delivery to 3 months post-delivery
Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants Abstinent From Drugs According to Urine
Time frame: Delivery to 3 months post-delivery
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Time frame: Delivery to 3 months post-delivery
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time frame: Delivery to 3 months post-delivery
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time frame: Delivery to 3 months post-delivery
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Time frame: Delivery to 3 months post-delivery
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Time frame: Delivery to 3 months post-delivery
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Time frame: Delivery to 3 months post-delivery
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Time frame: Delivery to 3 months post-delivery

Results and safety

Results posted to the registry on 21 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brief Advice	91	86
MI-CBT	92	82

Primary outcome: Percentage of Days Used Drugs or Alcohol

Time frame: intake to delivery, an average of 21 weeks. Mean (Standard Deviation). Unit: percentage of days

Measure	Brief Advice n = 86	MI-CBT n = 82
Intake	18 (27)	21 (34)
Delivery	6 (17)	7 (22)

Brief Advice vs MI-CBT: p = 0.88, Mixed Models Analysis

Population analysed: all randomized participants

Primary outcome: Percentage of Days Used Drugs or Alcohol

Time frame: delivery to 3 months post-delivery. Mean (Standard Deviation). Unit: percentage of days

Measure	Brief Advice n = 83	MI-CBT n = 80
Delivery	6 (17)	7 (22)
3 months post-delivery	14 (25)	13 (24)

Brief Advice vs MI-CBT: p = 0.88, Mixed Models Analysis

Population analysed: all randomized participants with data from delivery and 3 months post-delivery

Primary outcome: Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol

Time frame: intake to delivery, an average of 21 weeks. Mean (Standard Deviation). Unit: percentage of days

Measure	Brief Advice n = 58	MI-CBT n = 63
Intake	14 (25)	15 (27)
Delivery	4 (11)	6 (20)

Brief Advice vs MI-CBT: p = 0.10, Mixed Models Analysis

Population analysed: All randomized participants without a baseline diagnosis of drug use or dependence.

Primary outcome: Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol

Time frame: Delivery to 3 months post-delivery. Mean (Standard Deviation). Unit: percentage of days

Measure	Brief Advice n = 55	MI-CBT n = 62
Delivery	4 (11)	6 (20)
3 months post-delivery	11 (20)	14 (27)

Brief Advice vs MI-CBT: p = 0.10, Mixed Models Analysis

Population analysed: All randomized participants without a baseline diagnosis for drug abuse or dependence with data available for time frame.

20 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brief Advice	0 of 86 (0%)	0 of 86 (0%)	Not reported
MI-CBT	0 of 82 (0%)	0 of 82 (0%)	Not reported

Limitations and caveats (from the sponsor): Did not acheive desired sample size; results were averaged across substances; women were not seeking substance abuse treatment (i.e. they were attending for prenatal care); treatment was brief

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19350369Yonkers KA, Howell HB, Allen AE, Ball SA, Pantalon MV, Rounsaville BJ. A treatment for substance abusing pregnant women. Arch Womens Ment Health. 2009 Aug;12(4):221-7. doi: 10.1007/s00737-009-0069-2. Epub 2009 Apr 7.
Background: PubMed 18956504Hine CE, Howell HB, Yonkers KA. Integration of medical and psychological treatment within the primary health care setting. Soc Work Health Care. 2008;47(2):122-34. doi: 10.1080/00981380801970244.
Background: PubMed 20859145Yonkers KA, Gotman N, Kershaw T, Forray A, Howell HB, Rounsaville BJ. Screening for prenatal substance use: development of the Substance Use Risk Profile-Pregnancy scale. Obstet Gynecol. 2010 Oct;116(4):827-833. doi: 10.1097/AOG.0b013e3181ed8290.
Background: PubMed 22489543Quesada O, Gotman N, Howell HB, Funai EF, Rounsaville BJ, Yonkers KA. Prenatal hazardous substance use and adverse birth outcomes. J Matern Fetal Neonatal Med. 2012 Aug;25(8):1222-7. doi: 10.3109/14767058.2011.602143. Epub 2012 May 11.
Results publication: PubMed 22795046Yonkers KA, Forray A, Howell HB, Gotman N, Kershaw T, Rounsaville BJ, Carroll KM. Motivational enhancement therapy coupled with cognitive behavioral therapy versus brief advice: a randomized trial for treatment of hazardous substance use in pregnancy and after delivery. Gen Hosp Psychiatry. 2012 Sep-Oct;34(5):439-49. doi: 10.1016/j.genhosppsych.2012.06.002. Epub 2012 Jul 12.
Derived from this study: PubMed 28270105Xu X, Yonkers KA, Ruger JP. Economic evaluation of a behavioral intervention versus brief advice for substance use treatment in pregnant women: results from a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Mar 7;17(1):83. doi: 10.1186/s12884-017-1260-5.
Derived from this study: PubMed 24447885Forray A, Gotman N, Kershaw T, Yonkers KA. Perinatal smoking and depression in women with concurrent substance use. Addict Behav. 2014 Apr;39(4):749-56. doi: 10.1016/j.addbeh.2013.12.008. Epub 2013 Dec 17.
Individual participant dataSharing planned: No. only aggregate de-identified data

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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, M.D. 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 Phase 2 study testing MI-CBT and Brief Advice in people with Alcohol Abuse and Cocaine Abuse, 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 1 inclusion and 2 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 15 Apr 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2013). 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?

Percentage of Days Used Drugs or Alcohol (time frame: intake to delivery, an average of 21 weeks). The study lists 6 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 NCT00227903, which also lists 7 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 15 Apr 2020.