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Completed

NCT Number: NCT03953612

The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders

To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the role of neuroactive steroids in individuals with cocaine use disorder (CUD).

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Key information

Conditions

Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Yale Stress Center

New Haven, Connecticut, 06519, United States

About this study

This experimental study aims to examine the effects of PREG on a) repeated cocaine craving, mood and neurobiological reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily cocaine intake, craving, cognition and mood in men and women with CUD; and c) sex differences in all of these outcomes. The study's hypothesis is that PREG vs PLA will dose-specifically decrease stress-induced and drug-cue induced cocaine craving, improve mood and cognitive performance, and normalize hypothalamic pituitary adrenal (HPA) axis response to stress and drug-cue imagery, and reduce cocaine intake and craving in daily life in individuals with CUD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female individuals, ages 18 to 60.
  • 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.
  • Subject has voluntarily given informed consent and signed the informed consent document.
  • Able to read English and complete study evaluations.

Exclusion criteria

  • Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
  • Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/PCP, excluding alcohol and nicotine.
  • Any current use of opiates or past history of opiate use disorder.
  • Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
  • Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
  • 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.
  • Abstinent from cocaine for more than two weeks prior to admission.
  • Hypotensive individuals with sitting blood pressure below 90/50 mmHG.

Treatment and study plan

Pregnenolone (PREG)

Drug

2 doses of PREG (300 or 500 mg/day)

Placebos

Drug

placebo

Primary outcomes

  1. Craving Change in Stress and Cue Relative to Neutral

    Time frame: Experiment during treatment week 2

    Cocaine craving assessed in a laboratory experiment with exposure to stress, cocaine cue and neutral control condition in those receiving PREG (300mg; 500mg) vs Placebo. Cocaine craving was assessed using the Cocaine Craving Questionnaire (CCQ), a brief 10-item self-report craving scale that ranges in mean score from 1 to 7, where a higher score indicates higher craving. Data presented here is craving change in stress relative to neutral and craving change in cue relative to neutral, where the possible range in mean change score is -6 to +6.

Secondary outcomes

  1. Anxiety Change in Stress and Cue Relative to Neutral

    Time frame: Experiment during treatment week 2

    Anxiety assessed in laboratory experiment with exposure to stress, cocaine cue and neutral control condition in participants receiving PREG (300mg; 500mg) vs. Placebo treatment. Anxiety was assessed using a 10-point visual analog scale (VAS) in which 0="not at all" and 10="extremely high", with the mean score ranging from 0 to 10, and where higher score means higher anxiety. Data presented here is anxiety change in stress relative to neutral and anxiety change in cue relative to neutral, where the possible range in mean change score is -10 to +10.

  2. Cortisol Level Change in Stress and Cue Relative to Neutral

    Time frame: Experiment during treatment week 2

    Plasma was collected at each laboratory session to measure cortisol level and assess change in cortisol response to stress and cocaine cue relative neutral imagery condition exposure. Data presented here are change in cortisol level (mg/dl) in stress relative to neutral condition and cue relative to neutral condition.

  3. Pregnenolone Concentration

    Time frame: between weeks 2-3 of treatment

    Blood plasma concentration of pregnenolone in two doses of PREG (300mg; 500mg), and matching placebo, assessed over a 24 hour period.

Other outcomes

  1. Cocaine Dollar Amount During Trial Period

    Time frame: up to 8 weeks

    Mean dollar amount of cocaine per use day was assessed by daily self report on the Timeline Followback Substance Use Calendar and corroborated by daily self-reporting on smartphone (measurement unit in dollars).

  2. Mean Percent Cocaine Days

    Time frame: up to 8 weeks

    The mean percent cocaine days as assessed by self report on daily smartphone monitoring and corroborated by the Timeline Followback Substance Use Calendar over the 8 week period.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 16, 2019
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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