Drug Use Disorders During PregnancyPhase 2/3HOME IINCT01177982
Reinforcement-Based Treatment for Pregnant Drug Abusers
A Phase 2/3 study testing Usual RBT (t-RBT), Reduced RBT (r-RBT) and Abbreviated RBT (a-RBT) in people with Drug Use Disorders During Pregnancy, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Objectives: This project is a Stage II behavioral development study designed to answer remaining critical questions necessary before disseminating Reinforcement Based Treatment (RBT) to the larger treatment community. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Use Disorders During Pregnancy
- What is being tested?
- Usual RBT (t-RBT), Reduced RBT (r-RBT) and Abbreviated RBT (a-RBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 46 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Treatment entry at or before 34 weeks EGA with singleton fetus.
- Evidence of opioid, cocaine and/or other primary illicit substance use.
Who cannot join
- Severe medical or psychiatric concomitant condition interfering with treatment or needing hospitalization.
- Age 17 years or younger.
- Geographical constraints. These women are admitted only for a residential detoxification and often have plans to obtain aftercare in an outpatient or residential facility in closer proximity to their home. Thus, this greater distance from CAP increases the likelihood that these women will not return to CAP and will not deliver in a hospital that functions under similar protocols that operate in Baltimore City for treating drug-exposed neonates.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Objectives: This project is a Stage II behavioral development study designed to answer remaining critical questions necessary before disseminating Reinforcement Based Treatment (RBT) to the larger treatment community. These questions focus on the levels of intensity of RBT most efficacious for substance-using pregnant patients. Design: The proposed study utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple assignment randomized trial (SMART) design. Participants (N=220) will first be randomized at treatment outset into either treatment-as-usual RBT or a reduced intensity RBT. All participants will receive a subsequent randomization based upon an assessment of their initial two weeks of treatment compliance. Early-non-compliant participants will be randomized to receive either the same or an increased level of RBT treatment intensity while early-compliant participants will be randomized to receive either the same or decreased level of treatment intensity and scope. Primary outcome measures include treatment completion, and maternal heroin, cocaine, and other illicit substance use. Secondary outcome measures include maternal measures of HIV risk behavior, and psychosocial functioning and neonatal measures of length of hospitalization, and birth outcomes. Significance: The proposed project's innovation includes: the novelty RBT, use of a cutting-edge SMART model, application of advanced statistical techniques and inclusion of a cost-effectiveness approach. The proposed project's significance is exceedingly high, as it will lay the foundation for later Stage III studies focused on dissemination of stepped care treatment programs for drug-addicted pregnant women that can be implemented not only in comprehensive care clinics but in diverse community settings that provide services to such women.
- Conditions
- Drug Use Disorders During Pregnancy
- Being tested
- Usual RBT (t-RBT), Reduced RBT (r-RBT), Abbreviated RBT (a-RBT), Enhanced RBT (e-RBT), Early compliant t-RBT
- Keywords
- pregnancy, opioid, cocaine, alcohol, benzodiazepines, neonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual RBT (t-RBT)Behavioural
Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social Club Job Club
Reduced RBT (r-RBT)Behavioural
Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach
Abbreviated RBT (a-RBT)Behavioural
Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation
Enhanced RBT (e-RBT)Behavioural
Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job Club Recovery housing CAP housing admission Recovery sponsor
Early compliant t-RBTBehavioural
r-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social club Job club
Early non-compliant t-RBTBehavioural
t-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job club e-RBT: Recovery housing CAP short term housing admission Recovery sponsor
Early compliant r-RBTBehavioural
a-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation r-RBT: Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach
Early non-compliant r-RBTBehavioural
r-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social Club Job Club
| Study group | Role | What they receive |
|---|---|---|
| Usual RBT (t-RBT) | Active comparator | Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job club Receives: Behavioral: Usual RBT (t-RBT) |
| Reduced RBT (r-RBT) | Experimental | Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social Club Job Club Receives: Behavioral: Reduced RBT (r-RBT) |
| Abbreviated RBT (a-RBT) | Experimental | Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation Receives: Behavioral: Abbreviated RBT (a-RBT); Behavioral: Early compliant r-RBT |
| Enhanced RBT (e-RBT) | Active comparator | Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job club Recovery housing CAP short term housing admission Recovery sponsor Receives: Behavioral: Enhanced RBT (e-RBT); Behavioral: Early non-compliant t-RBT |
| Early compliant t-RBT | Active comparator | r-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social club Job club Receives: Behavioral: Early compliant t-RBT |
| Early non-compliant t-RBT | Active comparator | t-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job club e-RBT: Recovery housing CAP short term housing admission Recovery sponsor Receives: Behavioral: Early non-compliant t-RBT; Behavioral: Early compliant r-RBT |
| Early compliant r-RBT | Experimental | a-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation r-RBT: Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Receives: Behavioral: Abbreviated RBT (a-RBT); Behavioral: Early compliant r-RBT |
| Early non-compliant r-RBT | Experimental | r-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social Club Job Club Receives: Behavioral: Early non-compliant t-RBT; Behavioral: Early non-compliant r-RBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Completion
Delivering a baby, regardless of delivery hospital, while enrolled in treatment.
Measured: Delivery (data extracted from medical record)
Substance use
Drug Use: Urinalysis testing and self reported use (days in past month) for opioids, cocaine and other illicit substance use.
Measured: Once monthly until delivery and at six weeks post-partum
Secondary outcomes (5)
Alcohol
Alcohol use: Urinalysis testing and self-reported (days in past month) of alcohol use
Measured: Once monthly until delivery and at six weeks post-partum
Maternal Obstetrical Course/Outcome
Available maternal data will be abstracted from the completed delivery record (i.e.., maternal urine toxicology results at delivery, complications during labor/delivery, placental abruption, type of delivery, maternal length of hospital stay).
Measured: Delivery (data extracted from medical record)
Birth outcomes
Available birth outcome data will be extracted from infant medical records (i.e., birth weight, gestational age, infant complications).
Measured: Delivery (data extracted from medical record)
Length of Hospital Stay
Length of hospital stay is an indicator of health and well-being. The total days in the Newborn Nursery, Pediatrics and Neonatal Intensive Care will be abstracted from the medical records.
Measured: Upon release of infant from hospital (data extracted from medical record)
APGAR scores
Scores assigned at 1 and 5 minutes and any additional Apgar scoring if applicable will be extracted from the infant medical record
Measured: Delivery (data extracted from medical record)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startJul 2009
- Primary completionJan 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Use Disorders During PregnancyStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, National Institute on Drug Abuse (NIDA)
- Investigators
- Margaret Chisolm, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177982
- Sponsor's protocol ID
- DA14979-06
- Other IDs
- R01DA014979, DCNBR
- Acronym
- HOME II
- Status last verified
- Jul 2015
- First submitted
- 6 Aug 2010
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reinforcement-Based Treatment for Pregnant Drug Abusers
- ClinicalTrials.gov ID
- NCT01177982
- Acronym / sponsor ID
- HOME II / DA14979-06
- Conditions
- Drug Use Disorders During Pregnancy
- Keywords
- pregnancy, opioid, cocaine, alcohol, benzodiazepines, neonate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Study start
- Jul 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: This project is a Stage II behavioral development study designed to answer remaining critical questions necessary before disseminating Reinforcement Based Treatment (RBT) to the larger treatment community. These questions focus on the levels of intensity of RBT most efficacious for substance-using pregnant patients. Design: The proposed study utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple assignment randomized trial (SMART) design. Participants (N=220) will first be randomized at treatment outset into either treatment-as-usual RBT or a reduced intensity RBT. All participants will receive a subsequent randomization based upon an assessment of their initial two weeks of treatment compliance. Early-non-compliant participants will be randomized to receive either the same or an increased level of RBT treatment intensity while early-compliant participants will be randomized to receive either the same or decreased level of treatment intensity and scope. Primary outcome measures include treatment completion, and maternal heroin, cocaine, and other illicit substance use. Secondary outcome measures include maternal measures of HIV risk behavior, and psychosocial functioning and neonatal measures of length of hospitalization, and birth outcomes. Significance: The proposed project's innovation includes: the novelty RBT, use of a cutting-edge SMART model, application of advanced statistical techniques and inclusion of a cost-effectiveness approach. The proposed project's significance is exceedingly high, as it will lay the foundation for later Stage III studies focused on dissemination of stepped care treatment programs for drug-addicted pregnant women that can be implemented not only in comprehensive care clinics but in diverse community settings that provide services to such women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Usual RBT (t-RBT) | Active comparator | Behavioral: Usual RBT (t-RBT)Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job club |
| Reduced RBT (r-RBT) | Experimental | Behavioral: Reduced RBT (r-RBT)Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social Club Job Club |
| Abbreviated RBT (a-RBT) | Experimental | Behavioral: Abbreviated RBT (a-RBT), Behavioral: Early compliant r-RBTIndividual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation |
| Enhanced RBT (e-RBT) | Active comparator | Behavioral: Enhanced RBT (e-RBT), Behavioral: Early non-compliant t-RBTIndividual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job club Recovery housing CAP short term housing admission Recovery sponsor |
| Early compliant t-RBT | Active comparator | Behavioral: Early compliant t-RBTr-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social club Job club |
| Early non-compliant t-RBT | Active comparator | Behavioral: Early non-compliant t-RBT, Behavioral: Early compliant r-RBTt-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job club e-RBT: Recovery housing CAP short term housing admission Recovery sponsor |
| Early compliant r-RBT | Experimental | Behavioral: Abbreviated RBT (a-RBT), Behavioral: Early compliant r-RBTa-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation r-RBT: Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach |
| Early non-compliant r-RBT | Experimental | Behavioral: Early non-compliant t-RBT, Behavioral: Early non-compliant r-RBTr-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social Club Job Club |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Treatment entry at or before 34 weeks EGA with singleton fetus.
- Evidence of opioid, cocaine and/or other primary illicit substance use.
Key exclusion criteria (3 listed)
- Severe medical or psychiatric concomitant condition interfering with treatment or needing hospitalization.
- Age 17 years or younger.
- Geographical constraints. These women are admitted only for a residential detoxification and often have plans to obtain aftercare in an outpatient or residential facility in closer proximity to their home. Thus, this greater distance from CAP increases the likelihood that these women will not return to CAP and will not deliver in a hospital that functions under similar protocols that operate in Baltimore City for treating drug-exposed neonates.
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 |
|---|---|---|
| Usual RBT (t-RBT)Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social Club Job Club | Behavioural | Usual RBT (t-RBT) |
| Reduced RBT (r-RBT)Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach | Behavioural | Reduced RBT (r-RBT) |
| Abbreviated RBT (a-RBT)Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation | Behavioural | Abbreviated RBT (a-RBT), Early compliant r-RBT |
| Enhanced RBT (e-RBT)Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job Club Recovery housing CAP housing admission Recovery sponsor | Behavioural | Enhanced RBT (e-RBT) |
| Early compliant t-RBTr-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social club Job club | Behavioural | Early compliant t-RBT |
| Early non-compliant t-RBTt-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job club e-RBT: Recovery housing CAP short term housing admission Recovery sponsor | Behavioural | Early non-compliant r-RBT, Early non-compliant t-RBT, Enhanced RBT (e-RBT) |
| Early compliant r-RBTa-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation r-RBT: Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach | Behavioural | Abbreviated RBT (a-RBT), Early compliant r-RBT, Early non-compliant t-RBT |
| Early non-compliant r-RBTr-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social Club Job Club | Behavioural | Early non-compliant r-RBT |
Primary outcome
Treatment Completion
Time frame: Delivery (data extracted from medical record)
Delivering a baby, regardless of delivery hospital, while enrolled in treatment.
Substance use
Time frame: Once monthly until delivery and at six weeks post-partum
Drug Use: Urinalysis testing and self reported use (days in past month) for opioids, cocaine and other illicit substance use.
5 secondary outcomes
Alcohol
Time frame: Once monthly until delivery and at six weeks post-partum
Maternal Obstetrical Course/Outcome
Time frame: Delivery (data extracted from medical record)
Birth outcomes
Time frame: Delivery (data extracted from medical record)
Length of Hospital Stay
Time frame: Upon release of infant from hospital (data extracted from medical record)
APGAR scores
Time frame: Delivery (data extracted from medical record)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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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.
Margaret Chisolm, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Usual RBT (t-RBT), Reduced RBT (r-RBT) and Abbreviated RBT (a-RBT) in people with Drug Use Disorders During Pregnancy, run by National Institute on Drug Abuse (NIDA) at 1 site 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 2 inclusion and 3 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment Completion (time frame: Delivery (data extracted from medical record)). 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?
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 11 Jan 2017.