32 female cocaine users hospitalized for detoxification will receive six 4 IU jets of intranasal oxytocin twice daily (daily dose of 48 IU) as adjunctive treatment to conventional treatment from the eighth to seventeenth day of hospitalization (duration of oxytocin treatment of 10 days). Conventional treatment includes supportive individual and group psychotherapy (once a week), nutritional control, regular physical activity and psychopharmacotherapy as needed to relieve the symptoms of anxiety, aggression and agitation typical of withdrawal and care. 21 days of hospitalization.

32 female cocaine users hospitalized for detoxification will receive six jets of placebo solution (2% odor-generating propolis essence + the same vehicle as intra-nasal oxytocin: 0.05% citric acid, 0.9% sodium chloride, 1% glycerol, 0.54% disodium phosphate, 0.2% methylparaben + propylparaben, 1% sorbitol, 80% water) twice daily as adjunctive treatment to conventional treatment from the eighth to the seventeenth day of hospitalization (duration of placebo treatment of 10 days). Conventional treatment includes supportive individual and group psychotherapy (once a week), nutritional control, regular physical activity and psychopharmacotherapy as needed to relieve the symptoms of anxiety, aggression and agitation typical of withdrawal and care. 21 days of hospitalization.

32 female cocaine users hospitalized for detoxification will receive conventional treatment including individual and group supportive psychotherapy (once a week), nutritional control, regular physical activity and psychopharmacotherapy if needed for symptom relief. anxiety, aggression and agitation, typical of abstinence and nursing care, during 21 days of hospitalization.

Cocaine Withdrawal

Cocaine Smoking

Cocaine-Related Disorders

Oxytocin nasal spray 24 UI twice daily as adjunctive treatment to conventional treatment during 10 days of detoxification of crack cocaine

Oxytocin nasal spray

Nasal spray with placebo solution (2% odor-generating propolis essence + the same vehicle as intra-nasal oxytocin: 0.05% citric acid, 0.9% sodium chloride, 1% glycerol, 0.54% disodium phosphate, 0.2% methylparaben + propylparaben, 1% sorbitol, 80% water) twice daily as adjunctive treatment to conventional treatment.

placebo nasal spray

Hospital Santa Ana

Use of Intranasal Oxytocin During Detoxification of Crack Cocaine

Randomized, Double-Blind, Placebo Controlled Study of Intranasal Oxytocin During Detoxification of Crack Cocaine

Change from baseline withdrawal symptoms (hospital admission) at the end of detoxification treatment (21 days) assessed by Cocaine Selective Severity Assessment (CSSA, minimum and maximum scores: 0 - 112). After treatment, the oxytocin-treated group is expected to have significantly lower withdrawal scores (better outcome) than the other groups (30%).

Change from baseline anxiety symptoms (hospital admission) at the end of detoxification treatment (21 days) assessed by the Patient-Reported Outcomes Measurement Information System Short Form scale (PROMIS, minimum and maximum raw scores: 8 - 40). After treatment, the oxytocin-treated group is expected to show lower anxiety scores (better outcome) compared to the other groups (30%).

Change from baseline depressive symptoms (hospital admission) at the end of detoxification treatment (21 days) assessed by the Quick Inventory of Depressive Symptomatology Self-Report scale (QIDS-SR, minimum and maximum scores: 0 - 27). After treatment, the oxytocin-treated group is expected to show lower depressive scores (better outcome) compared to the other groups (30%).

Dose change of neuroleptic medications used during hospitalization for agitation or irritability (expected 25% lower).

Rate of adherence of outpatient treatment six months after discharge (expected to be 20% higher) assessed by reviewing the medical records of each patient within the outpatient program. If patient would be enrolled in the outpatient program after six months from detoxification she will be considered adhered to the program (higher rates means better outcome).

Rodrigo Grassi-Oliveira

Professor

Pontificia Universidade Católica do Rio Grande do Sul

Secretaria Nacional de Políticas sobre Drogas (SENAD)

Conselho Nacional de Desenvolvimento Científico e Tecnológico

On the eve of the eighth day of hospitalization, a person in charge of the research team performed a randomization of the participants exchanged in blocks, according to the methods of Schulz and collaborators (SCHULZ; GRIMES, 2002). The responsible person did not have contact with the participants. The blocks were made up of 12 participants each, and the ratio was maintained at 4: 4: 4, in order to reduce the chances of the groups getting mixed amounts. The members of the research team responsible for data collection, the technical team of the inpatient unit and the participants did not know to what condition each patient had been allocated.
These procedures guaranteed the randomization and double blinding of the study.

Subjects were randomly allocated to a group and entered a 4-week "washout period" during which no gum was chewed, followed by a 3-week treatment period (treatment period 1) during which Group A used Xylitol gum.(2 gum pieces, 3 times daily after meals for 6 minutes).Then underwent another 4-week washout period before entering treatment period 2 during which Group A used Gum Sorbitol

Subjects were randomly allocated to a group and entered a 4-week "washout period" during which no gum was chewed, followed by a 3-week treatment period (treatment period 1) during which Group B used sorbitol gum. Group B used Gum Sorbitol (2 gum pieces, 3 times daily after meals for 6 minutes).Then underwent another 4-week washout period before entering treatment period 2 during which Group B used Gum xylitol

Human Microbiome

Xylitol gum contains 70% xylitol in addition to gum base, natural flavors, soy lecithin, gum arabic, titanium dioxide, carnuba wax. Sorbitol gum was similar except that xylitol was replaced by 63% sorbitol and 2% maltitol and aspartame was included.

Xylitol then Sorbitol gum

Sorbitol gum was similar except that xylitol was replaced by 63% sorbitol and 2% maltitol and aspartame was included. Xylitol gum contains 70% xylitol in addition to gum base, natural flavors, soy lecithin, gum arabic, titanium dioxide, carnuba wax.

Sorbitol then Xylitol gum

Xylitol and Sorbitol Effects on the Oral Microbiome

Xylitol and Sorbitol Effects on the Microbiome of Saliva and Plaque

Profile microbial communities of saliva and plaque based high-throughput sequencing of the 16S rRNA gene.

sorbitol/schlaganfall

Use of Intranasal Oxytocin During Detoxification of Crack Cocaine

Xylitol and Sorbitol Effects on the Oral Microbiome

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