Phase 2
N=183
Therapeutic Substance Abuse Treatment in Pregnancy - 1
Alcohol Abuse · Cocaine Abuse · Marijuana Abuse
Bottom Line
View on ClinicalTrials.gov: NCT00227903 ↗Enrolled (actual)
183
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Percentage of Days Used Drugs or Alcohol — 18; 21; 6; 7 percentage of days — p=0.88
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MI-CBT (Behavioral); Brief Advice (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Days Used Drugs or Alcohol |
6; 7; 14; 13 | 0.88 |
| PRIMARY Percentage of Days Used Drugs or Alcohol |
6; 7; 14; 13 | 0.88 |
| PRIMARY Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol |
4; 6; 11; 14 | 0.10 |
| PRIMARY Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol |
4; 6; 11; 14 | 0.10 |
| PRIMARY Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol |
10; 13; 18; 8 | 0.10 |
| PRIMARY Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol |
10; 13; 18; 8 | 0.10 |
| SECONDARY Incidence of Preterm Births |
17; 8 | 0.08 |
| SECONDARY Incidence of Low Birth Weight |
17; 11 | 0.41 |
| SECONDARY Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report |
0.75; 0.76; 0.38; 0.41 | 0.79 |
| SECONDARY Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report |
0.75; 0.76; 0.38; 0.41 | 0.79 |
| SECONDARY Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine |
0.54; 0.56; 0.84; 0.84 | 0.88 |
| SECONDARY Proportion of Participants Abstinent From Drugs According to Urine |
0.84; 0.84; 0.52; 0.59 | 0.88 |
| SECONDARY Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine |
0.76; 0.75; 0.34; 0.33 | 0.50 |
| SECONDARY Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine |
0.76; 0.75; 0.34; 0.33 | 0.50 |
| SECONDARY 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 |
0.76; 0.81; 0.28; 0.44 | 0.07 |
| SECONDARY 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 |
0.76; 0.81; 0.28; 0.44 | 0.07 |
| SECONDARY 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 |
0.71; 0.61; 0.54; 0.31 | 0.07 |
| SECONDARY 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 |
0.71; 0.61; 0.54; 0.31 | 0.07 |
| SECONDARY Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine |
0.82; 0.85; 0.46; 0.58 | 0.91 |
| SECONDARY Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine |
0.82; 0.85; 0.46; 0.58 | 0.91 |
| SECONDARY Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine |
0.89; 0.78; 0.60; 0.63 | 0.91 |
| SECONDARY Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine |
0.89; 0.78; 0.60; 0.63 | 0.91 |
| SECONDARY 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 |
0.76; 0.76; 0.23; 0.35 | 0.04 sig |
| SECONDARY 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 |
0.76; 0.76; 0.23; 0.35 | 0.04 sig |
| SECONDARY 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 |
0.78; 0.67; 0.52; 0.25 | 0.04 sig |
| SECONDARY 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 |
0.78; 0.67; 0.52; 0.25 | 0.04 sig |
Summary
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).
Eligibility Criteria
Inclusion Criteria
Pregnant women, age 16 or older, alcohol or illicit drug use in the past 30 days -
Exclusion Criteria
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.
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Data sourced from ClinicalTrials.gov (NCT00227903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.