- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01963091
Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals
2 maj 2018 uppdaterad av: Megan Moran-Santa Maria, Medical University of South Carolina
Stress is associated with drug craving and relapse in substance-dependent individuals.
Hormones released from the brain may mediate the behavioral response to stress.
For example, several studies have indicated that oxytocin reduces stress in laboratory stress paradigms.
Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet, little is known about the potential affects of oxytocin in cocaine-dependent individuals.
Given these properties of oxytocin, it may have a therapeutic role in ameliorating the negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well as the anxiety associated with withdrawal.
This pilot protocol will provide important preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
33
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
South Carolina
-
Charleston, South Carolina, Förenta staterna
- Clinical Neurosciences Division-MUSC
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
1) General Inclusion / Exclusion Criteria Inclusion Criteria
- Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for a three-day period immediately prior to the CTRC admission. Nicotine dependence can affect HPA function therefore it would be ideal to exclude subjects with nicotine use. Because of the high comorbidity of cocaine and nicotine dependence, this would seriously compromise the feasibility of recruitment. In addition, because of the high comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse and dependence will be included if they do not require medically supervised detoxification. Due to the high comorbidity of cocaine and marijuana dependence, individuals with marijuana dependence will be included.
- Subjects must consent to random assignment.
- Subjects must consent to outpatient admission to the CTRC.
Exclusion Criteria
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- Women with premenstrual dysphoric disorder as this may impact on the response to the stress test procedure.
- Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses.
- Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status.
- Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
- Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response.
- Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with hormonal measurements within one month of test session.
- Subjects taking any psychotropic medications, opiates or opiate antagonists because these may affect test response. Subjects who have been maintained on SSRI's for 8 weeks will not be excluded.
- Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
- Subjects who are > 30% over ideal weight or have a BMI greater than 35 will be considered for study participation based on the clinical judgment of study staff.
- Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for three days prior to the stress task procedure.
- Subjects meeting DSM-IV criteria for substance dependence (other than alcohol, nicotine, marijuana orcocaine) within the past 60 days.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: placebo
|
Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm.
This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003).
Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt.
Pleasant, South Carolina).
Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
|
|
Experimentell: oxytocin
|
Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm.
This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003).
Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt.
Pleasant, South Carolina).
Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Salivary Cortisol Levels
Tidsram: 0 minutes post 15 minute stress task
|
salivary cortisol
|
0 minutes post 15 minute stress task
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Likert Scale Rating of Subjective Stress
Tidsram: 0 minutes post 15 minute stress task
|
Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'
|
0 minutes post 15 minute stress task
|
|
Likert Scale Rating of Subjective Craving
Tidsram: 0 mintues post 15 minute stress task
|
Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'
|
0 mintues post 15 minute stress task
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Megan Moran-Santa Maria, Ph.D., Medical University of South Carolina
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2011
Primärt slutförande (Faktisk)
1 oktober 2012
Avslutad studie (Faktisk)
1 oktober 2012
Studieregistreringsdatum
Först inskickad
13 juli 2011
Först inskickad som uppfyllde QC-kriterierna
11 oktober 2013
Första postat (Uppskatta)
16 oktober 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 juni 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 maj 2018
Senast verifierad
1 maj 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00009981
Läkemedels- och apparatinformation, studiedokument
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produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .