Khat Use DisorderMIkhatNCT02253589
Motivational Interviewing (MI) to Reduce Khat Use
A study testing modified ASSIST-linked Brief Intervention in people with Khat Use Disorder, run by University of Konstanz at 1 site in Kenya.
Trial summary
Healthy khat user with the intention to reduce or stop khat use will be randomly assigned to a one-session brief intervention or waiting list. Reductions in khat use will be measured from pre- to post-assessment which will be one month apart. After one month, the waiting list will receive the same intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Khat Use Disorder
- What is being tested?
- modified ASSIST-linked Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteKenya
- Study dates
- Oct 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals
Who cannot join
- Severe psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Motivational Interviewing (MI) to Reduce Khat Use Among Somali Refugees in Kenya
Healthy khat user with the intention to reduce or stop khat use will be randomly assigned to a one-session brief intervention or waiting list. Reductions in khat use will be measured from pre- to post-assessment which will be one month apart. After one month, the waiting list will receive the same intervention.
Read the detailed description
The leaves of the khat tree are traditionally chewed in some African and Arab countries. They contain the mild central stimulant cathinone. In recent years, the production, trade and use has dramatically increased and excessive patterns of use as well as a specific dependence syndrome have been described. So far, no experiences exist in psychological treatment of khat addiction.
In this study, we use a brief motivational intervention based on the WHO's ASSIST-linked Brief Intervention and Motivational Interviewing to support users who have the intention to reduce or stop their khat use. Khat users will be recruited in the community. Trained local staff will assess participant's khat and other substance use at study entry and one month later. Users will be assigned randomly to intervention or waiting list control groups. The intervention group will receive a single 20-minute brief intervention. The waiting list will receive the same intervention after the second assessment. After two months, a final assessment will be made in both groups.
- Conditions
- Khat Use Disorder
- Being tested
- modified ASSIST-linked Brief Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified ASSIST-linked Brief InterventionBehavioural
Also called Motivational Interviewing
Trained counsellors support participant's motivation to reduce or stop khat use in a 20 minute counselling session.
| Study group | Role | What they receive |
|---|---|---|
| Waiting list | No intervention | Participants will assessment only during study, same intervention after posttest |
| Intervention | Experimental | Participants assigned to this arm will receive the modified ASSIST-linked Brief Intervention Receives: Behavioral: modified ASSIST-linked Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-Line-Follow-Back: Self-reported days with khat use and amount of khat use
Participants report in a calender for each day of the past month whether they used khat and how much of it.
Measured: one month
Secondary outcomes (1)
Time-Line-Follow-Back: other substance use
Participants report for each day of the past month whether they used other substances of abuse, i.e. alcohol, illegal drugs
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Khat Use DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- Africa Institute of Mental and Brain Health (AFRIMEB)
- Responsible party
- Principal investigator, Michael Odenwald, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253589
- Sponsor's protocol ID
- 01DG13020
- Acronym
- MIkhat
- Status last verified
- May 2017
- First submitted
- 24 Sep 2014
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Widmann M, Apondi B, Musau A, Warsame AH, Isse M, Mutiso V, Veltrup C, Schalinski I, Ndetei D, Odenwald M. Reducing Khat use among Somalis living in Kenya: a controlled pilot study on the modified ASSIST-linked brief intervention delivered in the community. BMC Public Health. 2022 Dec 5;22(1):2271. doi: 10.1186/s12889-022-14681-w.
PubMed 36471268
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Motivational Interviewing (MI) to Reduce Khat Use Among Somali Refugees in Kenya
- ClinicalTrials.gov ID
- NCT02253589
- Acronym / sponsor ID
- MIkhat / 01DG13020
- Conditions
- Khat Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- Africa Institute of Mental and Brain Health (AFRIMEB)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthy khat user with the intention to reduce or stop khat use will be randomly assigned to a one-session brief intervention or waiting list. Reductions in khat use will be measured from pre- to post-assessment which will be one month apart. After one month, the waiting list will receive the same intervention.
Detailed description
The leaves of the khat tree are traditionally chewed in some African and Arab countries. They contain the mild central stimulant cathinone. In recent years, the production, trade and use has dramatically increased and excessive patterns of use as well as a specific dependence syndrome have been described. So far, no experiences exist in psychological treatment of khat addiction.
In this study, we use a brief motivational intervention based on the WHO's ASSIST-linked Brief Intervention and Motivational Interviewing to support users who have the intention to reduce or stop their khat use. Khat users will be recruited in the community. Trained local staff will assess participant's khat and other substance use at study entry and one month later. Users will be assigned randomly to intervention or waiting list control groups. The intervention group will receive a single 20-minute brief intervention. The waiting list will receive the same intervention after the second assessment. After two months, a final assessment will be made in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waiting list | No intervention | –Participants will assessment only during study, same intervention after posttest |
| Intervention | Experimental | Behavioral: modified ASSIST-linked Brief InterventionParticipants assigned to this arm will receive the modified ASSIST-linked Brief Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy individuals
Key exclusion criteria (1 listed)
- Severe psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified ASSIST-linked Brief InterventionAlso: Motivational InterviewingTrained counsellors support participant's motivation to reduce or stop khat use in a 20 minute counselling session. | Behavioural | Intervention |
Primary outcome
Time-Line-Follow-Back: Self-reported days with khat use and amount of khat use
Time frame: one month
Participants report in a calender for each day of the past month whether they used khat and how much of it.
1 secondary outcome
Time-Line-Follow-Back: other substance use
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Derived from this study: PubMed 36471268Widmann M, Apondi B, Musau A, Warsame AH, Isse M, Mutiso V, Veltrup C, Schalinski I, Ndetei D, Odenwald M. Reducing Khat use among Somalis living in Kenya: a controlled pilot study on the modified ASSIST-linked brief intervention delivered in the community. BMC Public Health. 2022 Dec 5;22(1):2271. doi: 10.1186/s12889-022-14681-w.
Related trials for Khat Use Disorder
Recruiting
Troubled-Desire & Therapeutic Chat for Reduction of CSAM Use (TD-CHAT)
Prevention, Well Being
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified ASSIST-linked Brief Intervention in people with Khat Use Disorder, run by University of Konstanz at 1 site in Kenya.
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 1 inclusion and 1 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 11 May 2017. 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 Kenya. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time-Line-Follow-Back: Self-reported days with khat use and amount of khat use (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02253589, which also lists 1 linked publication.
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 11 May 2017.