Trial Outcomes & Findings for A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users (NCT NCT02192931)

NCT ID: NCT02192931

Last Updated: 2025-04-08

Results Overview

Change in Hamilton Depression Rating Scale (HAMD) scores will be evaluated over the course of the 8-week treatment period. The HAMD provides an indication of depression and over time provides a valuable guide to progress. Total score ranges from 0 to 54. 0 means no depression and 24 and above means severe depression.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

8-weeks

Results posted on

2025-04-08

Participant Flow

We complied with safety measures meant to minimize the risk of exposure to COVID-19. Participant recruitment were facilitated by advertisements in newspapers, on the radio, by hanging recruitment materials, on the Internet, and by sending letters to social workers and staff at treatment centers. To increase the study's enrollment of healthy controls, we distributed materials specifically aimed at healthy controls.

Participant milestones

Participant milestones
Measure	Creatine Monohydrate 5 grams of daily creatine monohydrate for 8 weeks Creatine monohydrate	Placebo 5 g of placebo for 8 weeks Creatine monohydrate	Healthy Control Measured at baseline.
Overall Study STARTED	21	20	24
Overall Study COMPLETED	12	9	24
Overall Study NOT COMPLETED	9	11	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Creatine Monohydrate n=21 Participants 5 grams of daily creatine monohydrate for 8 weeks Creatine monohydrate	Placebo n=20 Participants 5 g of placebo for 8 weeks Creatine monohydrate	Healthy Control n=24 Participants Measured at baseline.	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=93 Participants	20 Participants n=4 Participants	24 Participants n=27 Participants	65 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	37.4 years STANDARD_DEVIATION 7.1 • n=93 Participants	34.2 years STANDARD_DEVIATION 10.0 • n=4 Participants	30.8 years STANDARD_DEVIATION 10.5 • n=27 Participants	33.8 years STANDARD_DEVIATION 9.6 • n=483 Participants
Sex: Female, Male Female	21 Participants n=93 Participants	20 Participants n=4 Participants	24 Participants n=27 Participants	65 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized Race · Caucasian	18 Participants n=93 Participants	17 Participants n=4 Participants	18 Participants n=27 Participants	53 Participants n=483 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized Race · More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized Race · Native American	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized Race · Hispanic/Latino	3 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	9 Participants n=483 Participants
Region of Enrollment United States	21 participants n=93 Participants	20 participants n=4 Participants	24 participants n=27 Participants	65 participants n=483 Participants

PRIMARY outcome

Timeframe: 8-weeks

Population: Due to participant attrition, data analyzed in one or more rows differed from the overall number analyzed.

Outcome measures

Outcome measures
Measure	Creatine Monohydrate n=20 Participants 5 grams of daily creatine monohydrate for 8 weeks Creatine monohydrate	Placebo n=19 Participants 5 g of placebo for 8 weeks Creatine monohydrate	Healthy Control n=24 Participants Healthy Control subjects did not receive study medication.
Hamilton Depression Rating Scale (HAMD) Scores Screening	16.76 score on a scale Standard Deviation 3.33	17.65 score on a scale Standard Deviation 4.66	1.67 score on a scale Standard Deviation 1.90
Hamilton Depression Rating Scale (HAMD) Scores Baseline Scan	16.24 score on a scale Standard Deviation 3.91	14.90 score on a scale Standard Deviation 4.10	1.58 score on a scale Standard Deviation 2.21
Hamilton Depression Rating Scale (HAMD) Scores Week 8 Final Scan	9.33 score on a scale Standard Deviation 3.58	8.18 score on a scale Standard Deviation 7.26	1.88 score on a scale Standard Deviation 2.58

SECONDARY outcome

Timeframe: 8-weeks

Population: Due to participant attrition, data analyzed on one or more rows differ from the overall number analyzed.

Change in Beck Anxiety Inventory (BAI) scores will be evaluated over the course of the 8-week treatment period. The BAI aims to assess the severity of anxiety symptoms, helping clinicians and researchers understand the level of anxiety an individual is experiencing. 0 means minimal anxiety and 30-63 means severe anxiety. The scale ranges from 0 to 63. Total score is reported.

Outcome measures

Outcome measures
Measure	Creatine Monohydrate n=20 Participants 5 grams of daily creatine monohydrate for 8 weeks Creatine monohydrate	Placebo n=19 Participants 5 g of placebo for 8 weeks Creatine monohydrate	Healthy Control n=24 Participants Healthy Control subjects did not receive study medication.
Beck Anxiety Inventory (BAI) Scores Week 8 Final Scan	6.00 score on a scale Standard Deviation 5.20	12.82 score on a scale Standard Deviation 18	3.64 score on a scale Standard Deviation 4.23
Beck Anxiety Inventory (BAI) Scores Screening	22.76 score on a scale Standard Deviation 12.70	29.25 score on a scale Standard Deviation 12.08	3.63 score on a scale Standard Deviation 4.67
Beck Anxiety Inventory (BAI) Scores Baseline	20.81 score on a scale Standard Deviation 12.00	24.60 score on a scale Standard Deviation 13.56	4.13 score on a scale Standard Deviation 4.67

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Phosphocreatine (Baseline comparison between creatine and placebo)

Neurochemistry, such as phosphocreatine (PCr), will be measured pre- and post-creatine/placebo treatment.

Outcome measures

Outcome measures
Measure	Creatine Monohydrate n=21 Participants 5 grams of daily creatine monohydrate for 8 weeks Creatine monohydrate	Placebo n=20 Participants 5 g of placebo for 8 weeks Creatine monohydrate	Healthy Control Healthy Control subjects did not receive study medication.
BL Neurochemistry Measured by Magnetic Resonance Spectroscopy	0.268 ratio Interval 0.251 to 0.285	0.268 ratio Interval 0.246 to 0.29	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 8-weeks

Population: Phosphocreatine (Treatment comparison between creatine and placebo)

Neurochemistry, such as phosphocreatine (PCr), will be measured pre- and post-creatine/placebo treatment.

Outcome measures

Outcome measures
Measure	Creatine Monohydrate n=12 Participants 5 grams of daily creatine monohydrate for 8 weeks Creatine monohydrate	Placebo n=9 Participants 5 g of placebo for 8 weeks Creatine monohydrate	Healthy Control Healthy Control subjects did not receive study medication.
Neurochemistry Measured by Magnetic Resonance Spectroscopy TX	0.291 ratio Interval 0.265 to 0.317	0.269 ratio Interval 0.251 to 0.287	—

Adverse Events

Creatine Monohydrate

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Healthy Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Creatine Monohydrate n=21 participants at risk 5 grams of daily creatine monohydrate for 8 weeks Creatine monohydrate	Placebo n=20 participants at risk 5 g of placebo for 8 weeks Creatine monohydrate	Healthy Control n=24 participants at risk Health Control subjects did not receive study medication.
Gastrointestinal disorders Diarrhea	14.3% 3/21 • week 8 Participant report	35.0% 7/20 • week 8 Participant report	0.00% 0/24 • week 8 Participant report

Additional Information

Danielle Boxer

University of Utah

Phone: 801-587-1549

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place