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Alcohol and Tobacco/Cannabis UsePhase 2R33NCT07828275

FASD Prevention R33

A Phase 2 study testing Intervention in people with Alcohol and Tobacco/Cannabis Use, run by Philadelphia College of Osteopathic Medicine at 1 site in South Africa.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This R33 application proposes to adapt and test an evidence-based behavioral intervention to decrease polysubstance use (i.e., alcohol and tobacco/cannabis) during pregnancy and lactation and prevent adverse clinical outcomes, including fetal alcohol spectrum disorder (FASD) in South Africa (SA). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Alcohol and Tobacco/Cannabis Use
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
1 siteSouth Africa
Study dates
1 Feb 2027to 30 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) be pregnant, (2) intend to breastfeed, (3) test positive for alcohol use by urinalysis (i.e., EtG), (4) test positive for tobacco or cannabis use by urinalysis (i.e., cotinine and THC), (5) have an independent access to a mobile phone, (6) plan to remain in the area during pregnancy and 3 months postpartum.

Who cannot join

  • Report serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past month.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yukiko Washio, PhD contact

(215) 871-6100

yukikowa@pcom.edu

South Africa1 site

  • University of Cape Town

    Cape Town

    Heather Jaspan, MD, PhD, +27 21 650 9111, hbjaspan@gmail.com

Other trials in South Africa

About this study

Official title: Adapting and Testing Behavioral Intervention to Prevent Fetal Alcohol Spectrum Disorders and Adverse Infant Outcomes (R33)

This R33 application proposes to adapt and test an evidence-based behavioral intervention to decrease polysubstance use (i.e., alcohol and tobacco/cannabis) during pregnancy and lactation and prevent adverse clinical outcomes, including fetal alcohol spectrum disorder (FASD) in South Africa (SA). SA has a long history of social and health disparities, resulting in the world's highest rate of FASD (111.1 per 1,000), where lifelong negative cognitive and physical effects result from prenatal alcohol exposure. FASD is completely preventable if women do not drink during pregnancy. Prenatal alcohol use frequently co-occurs with other substance use, especially tobacco and cannabis. The adverse effect on birth outcomes by alcohol and tobacco use together is worse than either substance alone. Recent evidence from animal models shows that prenatal exposure to both cannabinoids and alcohol potentiate the likelihood of alcohol-induced birth defects. Data from Cape Metropole, SA, showed that all women who reported prenatal alcohol use also tested positive for tobacco use, with 25% also reporting cannabis use. Alcohol use while breastfeeding also occurs at a relatively high rate in SA. Despite tremendous health benefits from breastfeeding, maternal alcohol use while breastfeeding significantly compromises infant development. Contingency management (CM) has been efficacious in reducing prenatal cocaine, alcohol, and tobacco use in the United States (U.S.). The Women's Health CoOp (WHC) is an evidence-based brief intervention addressing women-focused syndemic issues and resulting disparities associated with substance and alcohol use. These evidence-based interventions need to be combined and adapted for addressing maternal polysubstance use and associated health and behavioral issues during pregnancy and lactation in SA.

Being tested
Intervention, Usual Care
Keywords
prenatal alcohol use, prenatal tobacco use, prenatal cannabis use, alcohol use during lactation, tobacco use during lactation, cannabis use during lactation

What participants receive

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

  • InterventionBehavioural

    Participants will receive text-based support on health promotion and referral content based on educational components. Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if abstinence is verified.

  • Usual CareBehavioural

    Participants will receive community referrals to treatment programs as needed and will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample and fill out timeline follow-back. R200 will be provided for sample provision. Research staff will make referrals to treatment programs in the community as needed.

Study groups in NCT07828275
Study groupRoleWhat they receive
Usual CareActive comparatorParticipants will receive community referrals to treatment programs as needed and will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample and fill out timeline follow-back. R200 will be provided for sample provision. Research staff will make referrals to treatment programs in the community as needed.
Receives: Behavioral: Usual Care
InterventionExperimentalParticipants will receive text-based support on health promotion and referral content based on educational components. Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if abstinence is verified.
Receives: Behavioral: Intervention

What is being measured

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

  1. Urinalysis results for alcohol use

    An alcohol metabolite (EtG) will be measured in urine samples. EtG can be detected in the urine up to 5 days after heavy drinking and up to 2 days after light drinking with ≥150 ng/mL for EtG as a cutoff value.

    Measured: From enrollment to the end of treatment at 3 months postpartum

  2. Urinalysis results for tobacco use

    Biochemical verification of recent tobacco use in urine samples. A tobacco metabolite (cotinine) will be measured in urine samples. The metabolite can be detected up to 3-4 days after use with ≥ 80ng/mL as a cutoff.

    Measured: From enrollment to the end of treatment at 3 months postpartum

  3. Urinalysis results for cannabis use

    Biochemical verification of recent cannabis use in urine samples. A cannabis metabolite (THC) will be measured in urine samples. The metabolite can be detected up to 28 days after heavy use with ≥50 ng/mL as a cutoff.

    Measured: From enrollment to the end of treatment at 3 months postpartum

Secondary outcomes (7)

  1. Birth weight

    Birth weight

    Measured: Birth

  2. Gestational age at birth

    Gestational age at birth

    Measured: Birth

  3. Head circumference

    Head circumference

    Measured: Birth

  4. Apgar score

    Apgar score

    Measured: Birth

  5. NICU admission

    NICU admission and length of stay

    Measured: Birth to 3 months postpartum

  6. Infant weight at 3 months

    Infant weight at 3 months

    Measured: 3 months postpartum

  7. Infant height at 3 months

    Infant height at 3 months

    Measured: 3 months postpartum

Timeline

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

  1. First posted18 Sep 2026
  2. Study start1 Feb 2027 (estimated)
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07828275
Sponsor's protocol ID
H26-046
Acronym
R33
Status last verified
Sep 2026
First submitted
11 Sep 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A limited data set in which names and other personal health identifiers are removed will be supplied to researchers on request. The data will be made available after the publication of the study results. Analytic files will be collected in Redcap and then prepared in SPSS, R, SAS, or STATA, with online codebooks giving the variable name, label, type, format, positions, consistency codes, and, if applicable, values and value labels. Requesting access to data will involve drafting an abstract, checking the feasibility relative to the available data, and then seeking the permission of the principal investigator and the team for review, if appropriate. The data sets will be ready for use and can be converted to other analytic tools.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intervention in people with Alcohol and Tobacco/Cannabis Use, run by Philadelphia College of Osteopathic Medicine at 1 site in South Africa.

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 1 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: opening soon, as of the sponsor's last update on 18 Sep 2026. 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 South Africa. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yukiko Washio, PhD ((215) 871-6100, yukikowa@pcom.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinalysis results for alcohol use (time frame: From enrollment to the end of treatment at 3 months postpartum). The study lists 3 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 NCT07828275.

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 18 Sep 2026.

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