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Phase Pilot

Pregnenolone to Reduce Stress-Induced Cocaine Craving and Improve Treatment Outcome

  • Study HIC#:1603017466
  • Last Updated:07/15/2021

To test the preliminary efficacy of 200 mg and 400 mg of pregnenolone daily versus placebo in a dose-ranging study in individuals with cocaine use disorder. This proposal is a laboratory and treatment outcome study to examine the effects of pregnenolone on cocaine craving, mood and neurobiological reactivity to brief exposure to stress, drug cues and neutral situations in a sample of individuals with cocaine use disorder. We hypothesize that pregnenolone will be beneficial for reduction in stress and drug cue induced craving and related arousal. In a sample of 80 men and women with cocaine use disorder, we propose to examine (a) differences in measures of cocaine craving, emotion state, hypothalamic-pituitary-adrenal (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery and to drug cue imagery as compared to neutral imagery; (b) reduction in cocaine abstinence symptoms; and (c) improvement in cocaine treatment outcomes as measured by increasing abstinence, reduction in cocaine use and increased treatment attendance and (d) sex differences in all of these outcomes.

  • Age18 years and older
  • GenderBoth
  • Start Date07/21/2016
  • End Date07/31/2021

Trial Purpose and Description

To test the preliminary efficacy of 200 mg and 400 mg of pregnenolone daily versus placebo in a dose-ranging study in individuals with cocaine use disorder. This proposal is a laboratory and treatment outcome study to examine the effects of pregnenolone on cocaine craving, mood and neurobiological reactivity to brief exposure to stress, drug cues and neutral situations in a sample of individuals with cocaine use disorder. We hypothesize that pregnenolone will be beneficial for reduction in stress and drug cue induced craving and related arousal. In a sample of 80 men and women with cocaine use disorder, we propose to examine (a) differences in measures of cocaine craving, emotion state, hypothalamic-pituitary-adrenal (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery and to drug cue imagery as compared to neutral imagery; (b) reduction in cocaine abstinence symptoms; and (c) improvement in cocaine treatment outcomes as measured by increasing abstinence, reduction in cocaine use and increased treatment attendance and (d) sex differences in all of these outcomes.

Eligibility Criteria

Inclusion Criteria:

i. Male or female individuals, ages 18 and above.
ii. Subjects must meet current DSM-V criteria for cocaine use disorder; documented positive urine toxicology screen for cocaine at intake or collateral information from family members, significant others, room-mates etc., on recent use.
iii. Subject has voluntarily given informed consent and signed the informed consent document.
iv. Able to read English and complete study evaluations.

Exclusion Criteria:

i. Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
ii. Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/PCP, excluding alcohol and nicotine.
iii. Any current use of opiates or past history of opiate use disorder.
iv. Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
v. Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
vi. Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study.
vii. Abstinent from cocaine for more than two weeks prior to admission.
viii. Hypotensive individuals with sitting blood pressure below 90/50 mmHG.

Principal Investigator

Sub-Investigator

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