Progesterone for Cannabis Withdrawal
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|ClinicalTrials.gov Identifier: NCT03430050|
Recruitment Status : Completed
First Posted : February 12, 2018
Results First Posted : May 22, 2019
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cannabis Use Disorder Cannabis Withdrawal||Drug: Progesterone Drug: Placebo||Early Phase 1|
Substantial evidence demonstrates sex and gender differences in the behavioral, biological, and clinical correlates of substance use disorders. Men tend to initiate use earlier and have higher lifetime prevalence rates of disorder, but women demonstrate more severe withdrawal, more rapid progression from first use to disorder, and greater likelihood of comorbid psychiatric disorder. A growing literature suggests that the ovarian hormones progesterone and estradiol may play a key role in these differences. Evidence from preclinical and clinical research suggests that estradiol enhances drug sensitivity and related behavior, while progesterone attenuates drug sensitivity and behavior. As such, recent clinical trials investigating exogenous progesterone as a potential pharmacologic intervention have shown attenuated subjective and physiological effects of cocaine and nicotine in drug-dependent women, and improved cognitive performance in female smokers. While progesterone has shown promise as a treatment for women with cocaine and nicotine use disorder, it has not yet been tested for cannabis.
To date, there are no approved pharmacologic interventions for cannabis use disorder (CUD) despite numerous clinical trials. Cannabis withdrawal is one potential target for CUD medication development research as withdrawal increases risk of relapse. Important gender differences in cannabis withdrawal have been identified warranting gender-based investigation. Several studies have found that women experience more severe and impairing withdrawal symptoms, primarily physiological (e.g. stomach aches, headaches, nausea) and mood-related (e.g. irritability, mood swings), compared to men. As a naturally occurring sex hormone, progesterone may effectively address these gender differences. The proposed pilot study investigates the feasibility and efficacy of exogenous progesterone administration for cannabis withdrawal among female cannabis users.
Specific Aim 1: Test the feasibility of exogenous progesterone administration among cannabis users.
Hypothesis 1: Exogenous progesterone administration will induce normative elevations in progesterone comparable to the luteal phase of female menstrual cycle and will be well-tolerated by participants.
Specific Aim 2: Examine the efficacy of exogenous progesterone on cannabis withdrawal.
Hypothesis 2: Compared to placebo, progesterone will attenuate withdrawal symptoms among heavy-cannabis-using women.
Exploratory Aim: Examine the effect of exogenous progesterone on cognitive functioning during cannabis withdrawal.
Exploratory hypothesis: Compared to placebo, progesterone will enhance cognitive functioning among heavy-cannabis-using women.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Progesterone for the Treatment of Cannabis Withdrawal|
|Actual Study Start Date :||October 16, 2017|
|Actual Primary Completion Date :||April 4, 2018|
|Actual Study Completion Date :||April 4, 2018|
Active Comparator: Progesterone
Prometrium 200mg. Take one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5.
Other Name: Prometrium
Placebo Comparator: Placebo
Placebo. ake one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5.
Placebo capsule. Manufactured to mimic progesterone 200mg capsule.
Other Name: Inactive comparator
- Change in Salivary Progesterone Level [ Time Frame: Day 1 and Day 5 ]Participants took progesterone or placebo for 5 days. Salivary progesterone was measured each day. Change score was calculating by subtracting Day 1 progesterone levels from Day 5 progesterone levels.
- Change in Cannabis Withdrawal Scale Score. [ Time Frame: Day 1 and Day 5 ]Participants took progesterone or placebo for 5 days. The Cannabis Withdrawal Scale was administered each day. The 19-item scale is used to measure cannabis withdrawal symptoms and negative impact on daily life. The item scores range from 0 - not at all to 10- Extremely. Scores on all items are summed to attain the scale score, so individuals can score between 0-190. Higher scores indicates more severe withdrawal symptoms and greater negative impact. Change score was calculating by subtracting Day 1 CWS scores from Day 5 CWS scores. A positive change score reflects an increase in withdrawal symptoms, while a negative change score reflects a decrease in withdrawal symptoms.
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): NCT03430050
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29403|
|Principal Investigator:||Brian J Sherman, PhD||Medical University of South Carolina|