Cocaine WithdrawalPhase 1/2NCT04306354
Use of Intranasal Oxytocin During Detoxification of Crack Cocaine
A Phase 1/2 study testing Oxytocin nasal spray and Conventional Inpatient Treatment in people with Cocaine Withdrawal and Cocaine Smoking, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
Trial summary
This study investigated whether adding oxytocin nasal spray to usual inpatient treatment could reduce withdrawal, anxiety, and depressive symptoms in women hospitalized for cocaine detoxification. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Cocaine Withdrawal, Cocaine Smoking, Cocaine-Related Disorders
- What is being tested?
- Oxytocin nasal spray and Conventional Inpatient Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Sep 2018to 14 Jul 2020
- Phase
- Phase 1/2
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 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 18 to 52 years.
- Primary diagnosis of cocaine use disorder according to DSM-5 criteria. Other co-occurring substance use disorders were permitted, provided that cocaine was the primary drug of choice.
- Abstinence from cocaine for at least seven days before the intervention.
- Provision of informed consent and willingness to undergo random allocation to one of the study groups.
Who cannot join
- HIV-positive status.
- Pregnancy, postpartum status, or breastfeeding.
- Menopause.
- Current moderate or severe psychotic syndrome.
- Treatment with corticosteroids, synthetic glucocorticoids, or other exogenous hormone or steroid therapy.
- Intellectual impairment, defined as an intelligence quotient below 70.
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- An infectious condition or acute febrile syndrome.
- Diagnosed or suspected neurological disease or syndrome, including current or previous stroke, epilepsy, cancer, or neurodegenerative disease.
- Diagnosed or suspected autoimmune disease or syndrome.
- Diagnosed or suspected current decompensated or severe cardiovascular, pulmonary, renal, gastrointestinal, or endocrine disease.
- History of moderate or severe traumatic brain injury, specified in the manuscript as a Glasgow Coma Scale score below 12.
- Significant nasal congestion preventing intranasal administration.
- Type III nasal septal deviation with impaired breathing.
- Nasal mucosal lesions.
- Class III obesity.
- History of any hysterectomy or bilateral oophorectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Placebo Controlled Study of Intranasal Oxytocin During Detoxification of Crack Cocaine
This study investigated whether adding oxytocin nasal spray to usual inpatient treatment could reduce withdrawal, anxiety, and depressive symptoms in women hospitalized for cocaine detoxification.
A total of 84 women were randomly assigned to one of three groups: usual treatment plus oxytocin nasal spray (30 participants), usual treatment plus placebo nasal spray (29 participants), or usual treatment alone (25 participants). Participants receiving a nasal spray and the staff administering it did not know whether it contained oxytocin or placebo. The usual-treatment-only group did not receive a nasal spray and was not masked.
Symptoms were assessed during hospitalization, before, during, and after the intervention. Follow-up assessed relapse and duration of abstinence during the six months after discharge, using telephone contact with participants and family members and review of outpatient medical records. Outpatient treatment adherence was also a planned secondary outcome.
Read the detailed description
This study investigated whether adjunctive intranasal oxytocin could improve symptom reduction during inpatient detoxification in women with cocaine use disorder. It was conducted in a tertiary inpatient unit in Porto Alegre, Brazil.
Eligible participants who provided informed consent were randomly allocated to conventional treatment plus intranasal oxytocin, conventional treatment plus intranasal placebo, or conventional treatment alone. The placebo comparison evaluated the additional effects of oxytocin, while the conventional-treatment-only group provided a reference for symptom changes during usual inpatient care.
All groups received conventional inpatient treatment, including psychosocial interventions, nutritional care, physical activity, nursing care, and psychopharmacotherapy as clinically indicated. The intranasal intervention was administered during a 10-day period beginning on hospital day 8.
Participants and personnel administering the nasal spray were blinded to oxytocin versus placebo assignment. The conventional-treatment-only group received no nasal spray and was not masked.
Withdrawal and depressive symptoms were evaluated before, during, and after the intervention. The assessment windows were hospital days 1-4 for T1, days 8-11 for T2, and days 18-21 for T3. For participants receiving oxytocin or placebo, the final assessment was scheduled at least 24 hours after the last spray administration. Withdrawal symptoms were assessed using the Cocaine Selective Severity Assessment (CSSA), and depressive symptoms using the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR). Anxiety symptoms were also assessed using the PROMIS anxiety short form, as specified in the registered outcomes.
Concomitant psychotropic medication use during hospitalization was recorded to characterize medication exposure alongside symptom changes.
At the end of the six-month period following discharge, participants and their family members were contacted by telephone, and outpatient medical records were reviewed to obtain information on abstinence duration and relapse after discharge. Outpatient treatment adherence was also specified as a secondary outcome in the registered protocol.
- Being tested
- Oxytocin nasal spray, placebo nasal spray, Conventional Inpatient Treatment
- Keywords
- crack cocaine, addiction, stimulants, oxytocin, detoxification, abstinence, withdrawal
- Medical subject headings
- Cocaine Smoking, Cocaine-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Intranasal oxytocin was administered as six sprays containing 4 IU each (24 IU per administration), twice daily, for a total daily dose of 48 IU. Treatment was given from hospital day 8 through day 17, for 10 days, as an adjunct to conventional inpatient treatment.
placebo nasal sprayDrug
Intranasal placebo was administered as six sprays twice daily from hospital day 8 through day 17, for 10 days, as an adjunct to conventional inpatient treatment. The placebo contained the same vehicle as the oxytocin formulation, with 2% propolis essence added for odor matching.
Conventional Inpatient TreatmentOther
Conventional inpatient treatment included individual and group supportive psychotherapy once weekly, nutritional care, regular physical activity, nursing care, and psychopharmacotherapy as clinically indicated to manage withdrawal-related symptoms, including anxiety, aggression, and agitation. The planned inpatient treatment period was 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment Plus Intranasal Oxytocin (OXT) | Experimental | Participants received intranasal oxytocin in addition to conventional inpatient treatment. Each administration consisted of six sprays containing 4 IU each (24 IU per administration), given twice daily for a total daily dose of 48 IU. Treatment was administered from hospital day 8 through day 17, for 10 days.
Conventional treatment included individual and group supportive psychotherapy, nutritional care, regular physical activity, nursing care, and psychopharmacotherapy as clinically indicated to manage withdrawal-related symptoms. The planned inpatient treatment period was 21 days. Receives: Drug: Oxytocin nasal spray |
| Conventional Treatment Plus Intranasal Placebo (PBO) | Placebo comparator | Participants received intranasal placebo in addition to conventional inpatient treatment. Each administration consisted of six sprays of placebo solution, given twice daily from hospital day 8 through day 17, for 10 days. The placebo contained the same vehicle as the oxytocin formulation, with 2% propolis essence added for odor matching.
Conventional treatment included individual and group supportive psychotherapy, nutritional care, regular physical activity, nursing care, and psychopharmacotherapy as clinically indicated to manage withdrawal-related symptoms. The planned inpatient treatment period was 21 days. Receives: Drug: placebo nasal spray |
| Conventional Treatment Alone (CON) | Active comparator | Participants received conventional inpatient treatment alone, without intranasal oxytocin or placebo. Conventional treatment included individual and group supportive psychotherapy once weekly, nutritional care, regular physical activity, nursing care, and psychopharmacotherapy as clinically indicated to manage withdrawal-related symptoms, including anxiety, aggression, and agitation. The planned inpatient treatment period was 21 days. Receives: Other: Conventional Inpatient Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cocaine Withdrawal Symptoms
Change from baseline to the end of inpatient detoxification in the Cocaine Selective Severity Assessment (CSSA) total score. Total scores range from 0 to 112, with higher scores indicating greater withdrawal symptom severity. Change is calculated as the end-of-treatment score minus the baseline score; negative values indicate improvement.
Measured: Baseline (first week after hospital admission) and end of inpatient detoxification (up to hospital day 21).
Change in Anxiety Symptoms
Change from baseline to the end of inpatient detoxification in the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form raw total score. Raw total scores range from 8 to 40, with higher scores indicating greater anxiety symptom severity. Change is calculated as the end-of-treatment score minus the baseline score; negative values indicate improvement.
Measured: Baseline (first week after hospital admission) and end of inpatient detoxification (up to hospital day 21).
Change in Depressive Symptoms
Change from baseline to the end of inpatient detoxification in the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) total score. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. Change is calculated as the end-of-treatment score minus the baseline score; negative values indicate improvement.
Measured: Baseline (first week after hospital admission) and end of inpatient detoxification (up to hospital day 21).
Secondary outcomes (2)
Neuroleptic Dose Change
Dose change of neuroleptic medications used during hospitalization for agitation or irritability (expected 25% lower).
Measured: Change from baseline (first week after hospital admission) at the end of detoxification treatment (21 days)
Percentage of Participants Enrolled in Outpatient Treatment at Six Months
Percentage of participants enrolled in an outpatient treatment program six months after discharge from inpatient detoxification, as determined by review of outpatient medical records. Participants enrolled in the program at the six-month assessment are classified as adherent according to the study's operational definition. Higher percentages indicate greater outpatient treatment adherence.
Measured: Six months after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start17 Sep 2018
- Primary completion12 Jan 2020
- Study completion14 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine WithdrawalStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly allocated in a 1:1:1 ratio to three parallel groups: conventional inpatient treatment plus intranasal oxytocin, conventional inpatient treatment plus intranasal placebo, or conventional inpatient treatment alone. Randomization used blocks of 12 participants, with four assignments to each group, and was performed by a research team member who had no contact with participants.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Secretaria Nacional de Políticas sobre Drogas (SENAD), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Rodrigo Grassi-Oliveira, Pontificia Universidade Católica do Rio Grande do Sul
- Investigators
- Rodrigo Grassi-Oliveira, MD, PhD, Principal investigator, Pontifícia Universidade Católica do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306354
- Sponsor's protocol ID
- U1111-1188-6555
- Other IDs
- U1111-1188-6555, 39868314.0.0000.5336
- Status last verified
- Sep 2026
- First submitted
- 9 Mar 2020
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the study publications will be made available to qualified researchers upon reasonable request. The shared dataset will include relevant participant characteristics, treatment allocation, and outcome data, together with a data dictionary. Direct identifiers will be removed, and potentially identifying information will be reviewed before release to protect participant confidentiality.