Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study

• Sponsor: University of Arkansas (Other)
• Overall Status: Completed
• CT.gov ID: NCT00653263
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Methamphetamine use has escalated in recent years. Methamphetamine use has also spread throughout the country. Although much information has been gathered on the treatment of cocaine abuse, very little information has been obtained on the treatment of methamphetamine abuse. One of the first steps in developing appropriate treatment is to examine the effects of stopping a particular substance's use on individuals abusing that substance. To date this has not been well studied for people abusing methamphetamine. The purpose of this study is to better understand and develop accurate ways of measuring symptoms associated with stopping the use of methamphetamine in people that are abusing methamphetamine. If the withdrawal symptoms are able to be effectively measured, this will help to develop treatments targeted at alleviating these symptoms. These symptoms are often associated with relapse to use of that substance.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Dependence; Methamphetamine Withdrawal

Detailed Description

The primary aim of this 4 week observational study is to examine and characterize the withdrawal symptoms experienced by methamphetamine abusers who are recently abstinent from methamphetamine. The period of drug or substance withdrawal is often cited as the time during which risk of relapse use of that substance is very high. Therefore it is highly important to characterize specifically the withdrawal syndrome associated with cessation of methamphetamine use. This study will demonstrate our ability to recruit and work with this methamphetamine dependent population. In addition it will allow for the collection of pilot data to assist in selecting appropriate assessment tools in a submission of an RO1 grant for well-controlled studies characterizing methamphetamine withdrawal.

Study Design

• Study Type: Observational
• Actual Enrollment: 8 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Methamphetamine dependent Methamphetamine dependent participants admitted to Recovery Centers of Arkansas

Outcome Measures

Primary Outcome Measures

1. Methamphetamine Selective Severity Assessment (MSSA) [Baseline through week 4]

   Methamphetamine Selective Severity Assessment (MSSA) is an 18 item questionnaire assessing withdrawal symptoms with each question measured on a scale from 0(best score)-7(worst score) for a range in scores from 0(best score)-126(worst score). Higher scores indicate more severe withdrawal symptoms.

2. Methamphetamine Withdrawal Assessment (MAWA) [Baseline through week 4]

   The Methamphetamine Withdrawal Assessment (MAWA) is a 13 item questionnaire which measures symptoms of methamphetamine withdrawal on a scale from 0(best score)-4(worst score). The total score ranges from 0(best score)-52(worst score).

Secondary Outcome Measures

1. Hamilton Depression Rating Scale (HAM-D) Rating Score [4 weeks]

   Hamilton Depression rating scale (HAM-D)is a scale that covers 21 symptoms with a total score of 0(best score)-62 (worst score) and a cutoff for moderate depression of 15 or above.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18-65 years old

• Subjects must have a history of methamphetamine use, with recent use verified by a urine toxicology screen positive for amphetamines

Exclusion Criteria:

• Current diagnosis of drug or alcohol physical dependence (other than methamphetamine or tobacco)

• Schizophrenia, or bipolar type I disorder

• Present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that may affect mood ratings

• Current suicidality or psychosis

• Pregnancy: hormonal changes during pregnancy can affect mood which might produce a potential confound if pregnant women were enrolled

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

• University of Arkansas

Investigators

• Principal Investigator: Michael J Mancino, M.D., University of Arkansas
• Study Chair: Alison Oliveto, PhD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Institutional Center for Addiction Research site
• participant research link

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT00653263
• Other Study ID Numbers: 51178; Alcohol & Substance Dependence
• First Posted: Apr 4, 2008
• Last Update Posted: Jun 28, 2021
• Last Verified: Feb 1, 2010

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Arkansas: methamphetamine; drug abuse; withdrawal

Study Results

Participant Flow

Recruitment Details	A total of 13 participants were recruited for enrollment in study entry.
Pre-assignment Detail	A total of 5 participants did not meet study criteria and did not enter the study proper, leaving a total of 8 eligible subjects.

Arm/Group Title	Methamphetamine Dependent
Arm/Group Description	Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
Period Title: Overall Study
STARTED	8
COMPLETED	6
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Methamphetamine Dependent
Arm/Group Description	Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
Overall Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.67 (5.8)
Sex: Female, Male (Count of Participants)
Female	5 62.5%
Male	3 37.5%
Region of Enrollment (participants) [Number]
United States	8 100%

Outcome Measures

1. Primary Outcome

Title	Methamphetamine Selective Severity Assessment (MSSA)
Description	Methamphetamine Selective Severity Assessment (MSSA) is an 18 item questionnaire assessing withdrawal symptoms with each question measured on a scale from 0(best score)-7(worst score) for a range in scores from 0(best score)-126(worst score). Higher scores indicate more severe withdrawal symptoms.
Time Frame	Baseline through week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methamphetamine Dependent
Arm/Group Description	Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
Measure Participants	6
Mean (Standard Deviation) ["units on a scale"]	48.2 (26.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Methamphetamine Dependent
	Comments	Means and ranges were computed for the continuous baseline characteristics.For data with 5 time points (baseline and weeks 1 through 4), hypothesis tests were performed to test for a differences between baseline and each subsequent time point as well as differences between each time point For data with 3 time points hypothesis tests were performed to test for a differences between baseline and wk 2, wk 2 and wk 4, as well as between baseline and wk 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments

2. Primary Outcome

Title	Methamphetamine Withdrawal Assessment (MAWA)
Description	The Methamphetamine Withdrawal Assessment (MAWA) is a 13 item questionnaire which measures symptoms of methamphetamine withdrawal on a scale from 0(best score)-4(worst score). The total score ranges from 0(best score)-52(worst score).
Time Frame	Baseline through week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methamphetamine Dependent
Arm/Group Description	Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
Measure Participants	6
Mean (Standard Deviation) ["Units on a scale"]	20.3 (12.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Methamphetamine Dependent
	Comments	Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Hamilton Depression Rating Scale (HAM-D) Rating Score
Description	Hamilton Depression rating scale (HAM-D)is a scale that covers 21 symptoms with a total score of 0(best score)-62 (worst score) and a cutoff for moderate depression of 15 or above.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methamphetamine Dependent
Arm/Group Description	Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
Measure Participants	6
Mean (Standard Deviation) ["Units on a scale"]	18.5 (13.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Methamphetamine Dependent
	Comments	Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	Adverse events were collected for the entire duration of the study 18 months.
Adverse Event Reporting Description	No adverse events were identified as this was an observational study.
Arm/Group Title	Methamphetamine Dependent
Arm/Group Description	Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
All Cause Mortality
	Methamphetamine Dependent
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Methamphetamine Dependent
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Methamphetamine Dependent
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

The small sample size (N=6) is a significant limitation of the current study.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.