Methamphetamine DependenceNCT00653263
Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study
An observational study of Methamphetamine Dependence and Methamphetamine Withdrawal, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Methamphetamine Dependence, Methamphetamine Withdrawal
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will enroll 20 methamphetamine dependent individuals ages 18-65 recruited from those admitted to the Recovery Centers of Arkansas in North Little Rock.
Who may be able to join
- 18-65 years old
- Subjects must have a history of methamphetamine use, with recent use verified by a urine toxicology screen positive for amphetamines
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
Read the 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.
- Keywords
- methamphetamine, drug abuse, withdrawal
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Methamphetamine dependent | Methamphetamine dependent participants admitted to Recovery Centers of Arkansas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methamphetamine Selective Severity Assessment (MSSA)
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.
Measured: Baseline through week 4
Methamphetamine Withdrawal Assessment (MAWA)
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).
Measured: Baseline through week 4
Secondary outcomes (1)
Hamilton Depression Rating Scale (HAM-D) Rating Score
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startAug 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Methamphetamine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Mancino, M.D., Principal investigator, University of ArkansasAlison Oliveto, PhD, Study chair, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653263
- Sponsor's protocol ID
- 51178
- Other IDs
- Alcohol & Substance Dependence
- Status last verified
- Feb 2010
- First submitted
- 1 Apr 2008
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study
- ClinicalTrials.gov ID
- NCT00653263
- Acronym / sponsor ID
- 51178
- Keywords
- methamphetamine, drug abuse, withdrawal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 4 Apr 2008 (estimated)
- Results
- Posted 9 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methamphetamine dependent | – | –Methamphetamine dependent participants admitted to Recovery Centers of Arkansas |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll 20 methamphetamine dependent individuals ages 18-65 recruited from those admitted to the Recovery Centers of Arkansas in North Little Rock.
Key inclusion criteria (2 listed)
- 18-65 years old
- Subjects must have a history of methamphetamine use, with recent use verified by a urine toxicology screen positive for amphetamines
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Methamphetamine Selective Severity Assessment (MSSA)
Time frame: 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.
Methamphetamine Withdrawal Assessment (MAWA)
Time frame: 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).
1 secondary outcome
Hamilton Depression Rating Scale (HAM-D) Rating Score
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Mancino, M.D. principal investigator
University of Arkansas
Alison Oliveto, PhD study chair
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methamphetamine Dependence and Methamphetamine Withdrawal, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methamphetamine Selective Severity Assessment (MSSA) (time frame: Baseline through week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.