Alcohol Craving
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Oxytocin | 2.89 | 2.63 |
| Control | 3.08 | 2.71 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
NCT02058251Feb 2014 to Apr 2017
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
In comparison to the general population, military personnel and veterans are at increased risk of developing both substance use disorders (SUDs) and post-traumatic stress disorder (PTSD). Despite promising developments in the past decade, the treatment of patients with SUDs and comorbid PTSD is woefully inadequate (Back, 2010; Back et al., 2014; Brady et al., 2007; McCauley et al., 2012). One of the adverse effects of abused drugs is their long-term negative impact on social behavior that is thought to involve oxytocin (OT) dysregulation (McGregor et al., 2008). In preclinical and clinical experiments, local, intra-nasal, or systemic OT administration decreases activation of the amygdala in response to visual fearful/threatening stimuli (Kirsch et al., 2005), ameliorates the effects of stressful events, and decreases drug-taking and seeking behavior (McGregor et al., 2008; Baskerville and Douglas, 2010; Carson et al., 2010a; Bowen et al., 2011; Cox et al 2013). However, little attention has been focused on whether OT decreases SUD vulnerability after exposure to traumatic stress in preclinical or clinical studies. This clinical project will determine whether intra-nasally administered OT will decrease craving (Aim 1) to use alcohol and decrease stress reactivity (Aim 2) following exposure to laboratory-induced stress (Trier Social Stress Task) among veterans with a dual diagnosis of alcohol use disorder and PTSD.
Experimental
Oxytocin
Each participant will self-administer a 40 IU dose of intranasal oxytocin.
Placebo comparator
Control
Each participant will self-administer a 40 IU dose of intranasal saline.
Outcomes the sponsor listed as primary.
Alcohol Craving
Time frame · 2 hours
Using the Visual Analogue Scale (VAS), participants provided self-report ratings of subjective alcohol cravings on a scale of 1-10, with one being the lowest/better score, and 10 being the highest/worst outcome.
Stress Reactivity
Time frame · 2 hours
Salivary Cortisol (μg/dL). Greater cortisol levels are indicative of greater stress reactivity.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Oxytocin | 2.89 | 2.63 |
| Control | 3.08 | 2.71 |
| Group | Value (μg/dL) | Spread |
|---|---|---|
| Oxytocin | .14 | .10 |
| Control | .10 | .10 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OxytocinEach participant will self-administer a 40 IU dose of intranasal oxytocin. Oxytocin: One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants. | 0 / 35 | 0 / 35 | 0 / 35 |
| ControlEach participant will self-administer a 40 IU dose of intranasal saline. Placebo: Each participant will self-administer a 40 IU dose of intranasal saline. | 0 / 38 | 0 / 38 | 0 / 38 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Randomized controlled trial · 2021
Melkonian et al. 2021Journal of clinical psychopharmacologycited by 6
PMID 34121063PMC12869547DOI 10.1097/jcp.0000000000001434PUB-34121063
Indexing hint: Randomized controlled trial · 2019
Flanagan et al. 2019Experimental and clinical psychopharmacologycited by 39
PMID 30382728PMC6355345DOI 10.1037/pha0000232PUB-30382728
Who could join, as posted.
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