The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
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|ClinicalTrials.gov Identifier: NCT03872128|
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Drug: Pregnenolone Other: placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||random blind parallel|
|Official Title:||The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders|
|Actual Study Start Date :||September 27, 2018|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Active Comparator: patients receiving 300mg PREG
30 patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Active Comparator: patients receiving 500mg PREG
30 patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Placebo Comparator: placebo
30 patients randomly assigned to receive a placebo daily.
- Reduce alcohol use [ Time Frame: 8 weeks ]Change compared to baseline in percent heavy drinking days and any drinking days as well as number of drinks per drinking day will be the main outcomes. These will be assessed by self report on the Substance Use Calendar, daily smartphone monitoring and corroborated by weekly urine toxicology and breathalyzer screening.
- Alcohol craving reactivity in the laboratory [ Time Frame: in week 2 ]Alcohol craving assessed in laboratory experiment with exposure to stress, drug cues and neutral control condition in week 2 of PREG (300mg; 500mg) vs. Placebo treatment. Alcohol craving will be assessed using a 10-point visual analog scale (VAS) in which 0="not at all" and 10="extremely high".
- Neuroendocrine/cortisol reactivity [ Time Frame: in week 2 ]Plasma will be collected at each laboratory session to assess cortisol response to stress, drug cue and neutral imagery exposure.
- Cardiovascular functioning in the laboratory. [ Time Frame: 2 weeks ]An Electrocardiograph (ECG) monitor will be placed during the laboratory sessions in week 2 to assess change in heart rate and blood pressures.
- Weekly Perceived Stress [ Time Frame: 8 weeks ]Perceived Stress Scale from 0-4 with 4 being highest score.
- Provoked negative emotion and anxiety [ Time Frame: in week 2 ]Differential Emotion Scale (DES). Subjects will be asked to rate their current emotional state for the following subscales: anger, fear, sadness, anxiety, joy, neutral-relaxed feelings. Each subscale includes five adjectives (a total of 30 items) and will be used to describe each affect state and subjects are required to rate on a 5-point scale the extent to which each word describes the way s/he feels at the present time.
- Weekly alcohol craving [ Time Frame: weekly over the 8 week period ]Alcohol craving will be measured using the Alcohol Urge Questionnaire (AUQ), which is a brief 8-item self-report craving scale. Subjects are asked to rate on a Likert Scale ranging from 1-7 how strongly they disagree or agree with a statement regarding the urge for alcohol.
- Weekly Negative mood and anxiety [ Time Frame: 8 weeks ]The Hospital Anxiety and Depression Scale (HADS) will be used; it is a 7 item, brief measure of generalized symptoms of anxiety and fear. Respondents indicate how they currently feel and responses are rated on a 4-point Likert scale and range from 0 to 3.
- Provoked cognitive flexibility [ Time Frame: in week 2 ]Stroop Color Word Test during stress, drug cue and neutral provocation
- Adverse Events [ Time Frame: 8 weeks ]The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial.
- Alcohol withdrawal severity [ Time Frame: 8 weeks ]Alcohol withdrawal signs and symptoms will be measured weekly using the Clinical Institute Withdrawal Assessment (CIWA), which is a 13-item scale assessment. Items on this scale include objective measures (e.g., pulse), participants' responses to questions, such as orientation to time and space ("What day is this? Where are you? Who am I?"), and observations by the interviewer (evidence of tremor or paroxysmal sweats). Item responses range from 0 indicating no evidence of the symptom to 4 indicating highest severity of symptoms and possible total scores could range from 0 to 67.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872128
|Contact: Rajita Sinha, PhDfirstname.lastname@example.org|
|Contact: Julie Pinto, MS||203-737-5489|
|United States, Connecticut|
|Yale Stress Center||Recruiting|
|New Haven, Connecticut, United States, 06519|
|Contact: Rachel L Hart, MS 203-737-4791 email@example.com|
|Principal Investigator: Rajita Sinha, PhD|