Clinical trial NCT01177982: Reinforcement-Based Treatment for Pregnant Drug Abusers
Official title: Reinforcement-Based Treatment for Pregnant Drug Abusers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Drug Use Disorders During Pregnancy
Keywords: pregnancy, opioid, cocaine, alcohol, benzodiazepines, neonate
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Johns Hopkins University
First posted: 2010-08-09
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Treatment entry at or before 34 weeks EGA with singleton fetus.
2. Evidence of opioid, cocaine and/or other primary illicit substance use.

Exclusion Criteria:

1. Severe medical or psychiatric concomitant condition interfering with treatment or needing hospitalization.
2. Age 17 years or younger.
3. 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.

Primary outcomes:
measure: Treatment Completion
timeFrame: Delivery (data extracted from medical record)
measure: Substance use
timeFrame: Once monthly until delivery and at six weeks post-partum
Secondary outcomes:
measure: Alcohol
timeFrame: Once monthly until delivery and at six weeks post-partum
measure: Maternal Obstetrical Course/Outcome
timeFrame: Delivery (data extracted from medical record)
measure: Birth outcomes
timeFrame: Delivery (data extracted from medical record)
measure: Length of Hospital Stay
timeFrame: Upon release of infant from hospital (data extracted from medical record)
measure: APGAR scores
timeFrame: Delivery (data extracted from medical record)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Margaret Chisolm, MD
role: PRINCIPAL_INVESTIGATOR
References: